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Recognized Consensus Standards

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Recognition List Number: 030 FR 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 Development 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
Number
Device Name Device
Class
Product
Code
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW
§870.3610 Implantable Pacemaker Pulse-Generator Class 3 DXY
FDA Technical Contact:
 Mitchell J. Shein
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1316
  Silver Spring MD 20993
  301/796-6363
  email: mitchell.shein@fda.hhs.gov
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