BARD STINGER ABLATION CATHETERS
FDA premarket approval P000020/S003 · decided 2001-08-20
Approval details
- PMA number
- P000020
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BARD STINGER ABLATION CATHETERS
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2001-07-20
- Decision date
- 2001-08-20
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lowell, MA
- Statement
- APPROVAL FOR AN ADDITIONAL "G" CURVE CONFIGURATION AND ADDITIONAL LENGTH OF 85 CENTIMETERS FOR THE STINGER, STINGER M, AND STINGER S ABLATION CATHETERS.
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