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: TELIGEN ICD MODELS E102, E103, E110, E111
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific Corp; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P010012
• Supplement Number: S271
• Date Received: 08/19/2011
• Decision Date: 09/15/2011
• Product Code: LWP
• 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  
ALTERNATE SUPPLIERS FOR CERAMIC CAPACITORS.