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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceArctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St., Ms Mv S46
Mounds View, MN 55112
PMA NumberP100010
Supplement NumberS116
Date Received07/08/2021
Decision Date08/06/2021
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co., Villalba for full assembly, sterilization, packaging, and distribution.
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