SAFIRE ABLATION SYSTEM
FDA premarket approval P960016/S039 · decided 2012-09-10
Approval details
- PMA number
- P960016
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SAFIRE ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 2012-07-23
- Decision date
- 2012-09-10
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE PINION GEAR COMPONENT.
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