|
Device | ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADVANCE CRYOABLATION CATHETER |
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 | S026 |
Date Received | 05/03/2013 |
Decision Date | 10/03/2013 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW PROCESS FOR INCOMING INSPECTION OF CHECK VALVES. |