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: Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit
• Generic Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Applicant: Medtronic Cryocath, LP; 8200 Coral Sea St., Ms Mv S46; Mounds View, MN 55112
• PMA Number: P100010
• Supplement Number: S117
• Date Received: 07/09/2021
• Decision Date: 09/10/2021
• Product Code: OAE
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for an additional sterilization site.