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 | 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S109 |
Date Received | 03/01/2024 |
Decision Date | 03/29/2024 |
Product Code |
LPB |
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 minor manufacturing changes to the Arctic Front Advance (AFA) (2AF234 and 2AF284), Arctic Front Advance Pro (AFA Pro) (AFAPRO23 and AFAPRO28), Freezor (207F1, 207F3, 207F5), Freezor Xtra (217F1, 217F3, 217F5) and Freezor MAX (209F3 and 209F5) cryoablation catheters |
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