|
Device | CoolFlow 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 | S040 |
Date Received | 06/20/2018 |
Decision Date | 05/08/2019 |
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 of the addition of a second source supplier for the CoolFlow Irrigation Tubing Set, which is a manufacturing site located at: Lake Region Medical, Inc.Venusa de Mexico S. de R.L. de C.V.1525 Calle Hertz Street Parque Industrial Antonio J. BermudezCiudad Juarez, Chihuahua 32470 Mexico |