|
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 | S034 |
Date Received | 09/30/2010 |
Decision Date | 11/18/2010 |
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 DESIGN CHANGE TO THE HEADER COUPLING (FROM A MACHINED COMPONENT TO A MOLDED COMPONENT) OF THE OPTISENSE MODEL 1999 PACING AND SENSING LEAD. |