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Download 3-114 Card Implants for Surgery - Cardiac Pacemakers
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Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile 3-114 Card Connectors (IS-1) for Implantable Pacemakers 5841-3 Second edition 01/15/2013 ISO 2000-1015 Recognition List Number: 030 Publication Date: 01/15/2013 Part B: SUPPLEMENTARY INFORMATION Recognition Number 3-114: ISO 5841-3 Second edition 2000-10-15, Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers. (Cardiovascular) Date of Standard: 2000. Address of Standards Organization: International Organization for Standardization (ISO)* 1, Rue de Varembe Case Postale 56 CH 1211 Geneva 20, 0 SWITZERLAND CDRH Office and Division Associated with Recognized Standards: OFFICE OF DEVICE EVALUATION (ODE) DIVISION OF CARDIOVASCULAR DEVICES (DCD) Devices Affected: Implantable pacemakers, pacemaker lead and pacemaker lead adapters Processes Affected: 510(k), PMA, PDP, IDE, HDE, Quality System Regulation Type of Standard: International Extent of Recognition: Complete standard Related CFR Citations and Product Codes: Regulation Device Name Number Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Device Class Product Code Class 3 NIK21 Resynchronization (Crt-D) Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM22 Unclassified Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial Class 3 NVN23 (Ra) Pacemaker Electrodes Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS24 Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP25 Unclassified Permanent Defibrillator Electrodes Class 3 NVY26 Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Class 3 NKE27 Resynchronization (Crt-P) Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ28 Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO29 Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW §870.361031 Class 3 DXY32 Implantable Pacemaker Pulse-Generator Regulation Device Name Number §870.362033 Regulation Number §870.368035 Device Class 30 Product Code Class 2 DTD34 Pacemaker Lead Adaptor Device Name Permanent Pacemaker Electrode Device Class Product Code Class 3 DTB36 Relevant Guidance: "Guidance for the Submission of Research and Marketing Applications for Permanant Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions." DRAFT November 2000 [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR870.3610] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 870 -- CARDIOVASCULAR DEVICES Subpart D--Cardiovascular Prosthetic Devices Sec. 870.3610 Implantable pacemaker pulse generator. (a)Identification. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body. (b)Classification. Class III (premarket approval). (c)Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 20, 2012, for any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976. Any other implantable pacemaker pulse generator device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 37576, June 22, 2012] [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR870.3620] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 870 -- CARDIOVASCULAR DEVICES Subpart D--Cardiovascular Prosthetic Devices Sec. 870.3620 Pacemaker lead adaptor. (a)Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer. (b)Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions." [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR870.3680] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 870 -- CARDIOVASCULAR DEVICES Subpart D--Cardiovascular Prosthetic Devices Sec. 870.3680 Cardiovascular permanent or temporary pacemaker electrode. (a)Temporary pacemaker electrode --(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2)Classification. Class II (performance standards). (b)Permanent pacemaker electrode --(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2)Classification. Class III (premarket approval). (c)Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 FR 39927, July 6, 2012]
