Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download 3-110 Card Technical Information Report Active implantable medical
Document related concepts
Transcript
Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable 3Card cardioverter defibrillator lead TIR41:2011 01/15/2013 AAMI 110 connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators Recognition List Number: 030 Publication Date: 01/15/2013 Part B: SUPPLEMENTARY INFORMATION Recognition Number 3-110: AAMI TIR41:2011, Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators. (Cardiovascular) Date of Standard: 2011. Address of Standards Organization: Association for the Advancement of Medical Instrumentation (AAMI) 4301 North Fairfax Drive Suite 301 Arlington, VA 22203 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: PMA, PDP, IDE, HDE, Quality System Regulation Type of Standard: Vertical, 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 Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS23 Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP24 Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Class 3 NKE25 Resynchronization (Crt-P) Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ26 Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO27 Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW28 §870.361029 Class 3 DXY30 Implantable Pacemaker Pulse-Generator Relevant Guidance: There is no relevant guidance developed at this time. [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]
