|
Device | SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION) |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990071 |
Supplement Number | S027 |
Date Received | 04/07/2014 |
Decision Date | 07/02/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR HARDWARE MODIFICATIONS TO THE SMARTABLATE IRRIGATION PUMP THAT UPDATE THE HARDWARE FROM VERSION 1 TO VERSION 2. |