|
Device | THERMOCOOL™SMARTTOUCH, THERMOCOOL™SMARTTOUCH SF |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990071 |
Supplement Number | S049 |
Date Received | 04/12/2021 |
Decision Date | 04/27/2021 |
Product Code |
LPB |
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 Procedure to repackage and relabel products with secondary packaging damage. |