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: Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A
• Generic Name: Pulse generator, permanent, implantable
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. N.E; Ms Mvs11; Mounds View, MN 55112
• PMA Number: P980035
• Supplement Number: S473
• Date Received: 08/17/2016
• Decision Date: 09/01/2016
• Product Code: NVZ
• 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  
New annealing vacuum oven used during the manufacture of the battery cases.