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. |
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Device | Arctic Front Advance Cardiac Cryoablation Catheters |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MS MVS46 MOUNDS VIEW, MN 55112 |
PMA Number | P100010 |
Supplement Number | S094 |
Date Received | 05/16/2019 |
Decision Date | 06/04/2019 |
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 |
Approval Order Statement Approval for a manufacturing site located at:Medtronic, Inc.Medtronic Puerto Rico Operations Co.Rd. 149, Km 56.3, Call Box 6001Villalba, Puerto Rico 007766 USA |
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