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: INSYNC ICD
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P010031
• Supplement Number: S060
• Date Received: 12/14/2006
• Decision Date: 01/11/2007
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.