|
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 | S007 |
Date Received | 04/11/2005 |
Decision Date | 07/12/2005 |
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 REPLACING SOFTWARE VERSION 1.034B WITH VERSION 1.035. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR FOR CARDIAC ABLATION AND IS INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES. |