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: CAPSURE, VITATRON CRYSTALINE, VITATRON EXCELLENCE PS
• Generic Name: Permanent defibrillator electrodes
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P830061
• Supplement Number: S080
• Date Received: 10/17/2012
• Decision Date: 10/26/2012
• Product Code: NVY
• 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.