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 STREET; MOUNDS VIEW, MN 55112
• PMA Number: P020045
• Supplement Number: S071
• Date Received: 12/28/2015
• Decision Date: 01/14/2016
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
ACCEPTANCE OF CHANGES PERFORMED DURING SUB-COOLER PERFORMANCE TESTING.