|
Device | THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S039 |
Date Received | 02/21/2012 |
Decision Date | 06/15/2012 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATIVE STERILIZATION FACILITY LOCATED AT STERIGENICS US IN SANTA TERESA, NEW MEXICO. |