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: TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P920015
• Supplement Number: S116
• Date Received: 09/13/2013
• Decision Date: 10/10/2013
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
ADDITION OF AN ELLIPSOMETRY INSPECTION STEP FOR ETFE JACKETED WIRE AND CABLE COMPONENTS.