SAFIRE CARDIAC ABLATION SYSTEM
FDA premarket approval P960016/S034 · decided 2010-11-18
Approval details
- PMA number
- P960016
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SAFIRE CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2010-09-30
- Decision date
- 2010-11-18
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- 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.
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