|
Device | SAFIRE CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S018 |
Date Received | 04/26/2007 |
Decision Date | 06/08/2007 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING MODIFICATION THAT ALLOWS THE BOSTON MAESTRO 3000 RT GENERATOR TO BE USED WITH THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER AND EXTENSION CABLES. |