|
Device | CELSIUS CATHETER, CELSIUS RMT CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S050 |
Date Received | 04/03/2014 |
Decision Date | 07/02/2014 |
Product Code |
LPB |
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 APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY. |