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: FREEZOR CARDIAC CRYOABLATION SYSTEM
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Medtronic Cryocath, LP; 8200 Coral Sea St.; Mounds View, MN 55112
• PMA Number: P020045
• Supplement Number: S072
• Date Received: 12/28/2015
• Decision Date: 01/27/2016
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ACCEPTANCE FOR NEW ASSEMBLY AREA FOR REPLACEMENT PARTS THAT ARE USED FOR CONSOLE REPAIR AND SERVICING.