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 | Manual Retraction Kit |
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 | S136 |
Date Received | 01/30/2023 |
Decision Date | 02/28/2023 |
Product Code |
OAE |
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 Transfer of the Arctic Front family of Cardiac Cryoablation Catheters and its Manual Retraction Kit Accessory (20MRK) from Medtronic's Montreal facility to Medtronic's Tijuana Mexico facility in addition to the implementation of manufacturing changes and minor updates to the packaging design. |
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