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: INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: BOSTON SCIENTIFIC; 4100 Hamline Avenue North; St. Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S253
• Date Received: 03/01/2012
• Decision Date: 03/30/2012
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: Yes
• Recalls: CDRH Recalls

Approval Order Statement  
REMOVE AN INSERTION FORCE PROCESS MONITOR.