|
Device | SmartAblate Irrigation Tubing Set |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990071 |
Supplement Number | S053 |
Date Received | 02/16/2022 |
Decision Date | 03/15/2022 |
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 Transfer of quality inspection for the SmartAblate Irrigation Tubing Set from BWI Irwindale to Venusa De Mexico S. De R.L De C.V, DBA Lake Region Medical (LRM), a previously approved supplier. |