Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM
• Classification Name: catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Applicant: MEDTRONIC CRYOCATH LP
• PMA Number: P100010
• Supplement Number: S001
• Date Received: 01/12/2011
• Decision Date: 08/23/2011
• Product Code: OAE [ Registered Establishments with OAE ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.