|
Device | STOCKERT 70 RADIOFREQUENCY GENERATOR 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 | S020 |
Date Received | 08/17/2012 |
Decision Date | 11/20/2012 |
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 SOFTWARE AND HARDWARE MODIFICATIONS IMPLEMENTED TO MAKE THE DEVICE COMPLIANT TO IEC 60601-1 3RD EDITION. |