|
Device | ARTIC FRONT CYROABLATION 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 | S040 |
Date Received | 06/27/2014 |
Decision Date | 07/25/2014 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00523978
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ALTERNATE SUPPLIER FOR CONNECTORS AND CONNECTOR FITTINGS AND ACCEPTANCE OF AN ALTERNATE ADHESIVE CURING PROCESS. |
Post-Approval Study | Show Report Schedule and Study Progress |