|
Device | ARCTIC FRONT CRYOABLATION CATHETER; ARCTIC 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 | S035 |
Date Received | 03/05/2014 |
Decision Date | 04/03/2014 |
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 UPDATES TO THE MANUFACTURING STEPS AND FIXTURES AT MANUFACTURING STATION P09 Y BLOCK TO SHAFT ASSEMBLY USED IN THE MANUFACTURE OF THE ARCTIC FRONT AND ARCTIC FRONTADVANCE CATHETERS. |