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 MODEL 7272
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P010031
• Supplement Number: S297
• Date Received: 03/07/2012
• Decision Date: 04/02/2012
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.