|
Device | SmartAblate Irrigation Pump, nGEN Pump Devices |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990071 |
Supplement Number | S042 |
Date Received | 01/03/2019 |
Decision Date | 04/29/2019 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the user manuals of the SmartAblate Irrigation Pump and nGEN Pump to claim compatibility with the ThermoCool SmartTouch Catheter family. |