Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES (ICD AND CRT-D)
• Generic Name: Pulse generator, permanent, implantable
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P910023
• Supplement Number: S083
• Date Received: 09/19/2005
• Decision Date: 10/17/2005
• Product Code: NVZ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ELIMINATION OF A REDUNDANT WELD OPERATION DURING THE ASSEMBLY OF THE HIGH VOLTAGE CAPACITOR FOR THE ICD/CRT-D DEVICES.