STINGER, STINGER S, STINGER M, & STINGER SM ABLATION CATHETER
FDA premarket approval P000020/S009 · decided 2005-06-16
Approval details
- PMA number
- P000020
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STINGER, STINGER S, STINGER M, & STINGER SM ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2005-04-18
- Decision date
- 2005-06-16
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lowell, MA
- Statement
- APPROVAL FOR PACKAGING CHANGES FOR THE BARD STINGER, STINGER S, STINGER M, AND STINGER SM ABLATION CATHETER.
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