STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE
FDA premarket approval P000020/S007 · decided 2002-08-19
Approval details
- PMA number
- P000020
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2002-07-10
- Decision date
- 2002-08-19
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lowell, MA
- Statement
- APPROVAL FOR THE LINE OF STINGER CATHETERS CONFIGURED WITH AN 8F/5MM DISTAL ELECTRODE.
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