Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S055 |
Date Received | 06/24/2022 |
Decision Date | 01/24/2023 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for alternate components; changes in sterilization monitoring; an alternate physical manufacturing site at Harmac Medical Products, Inc. H3 de Tijuana S. de RL de CV Calle Maquiladoras No. 320-A Col. Ciudad Industrial Nueva Tijuana CP 22500 Mexico; and an alternate sterilization site at STERIS AST, 1000 Sarah Place, Ontario, CA 91761 USA. |
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