STINGER(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE
FDA premarket approval P000020/S002 · decided 2001-02-07
Approval details
- PMA number
- P000020
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STINGER(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2001-01-09
- Decision date
- 2001-02-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lowell, MA
- Statement
- APPROVAL FOR THE STINGER M ABLATION CATHETER (MODELS 210001M - 210006M) AND THE TEMPLINK M CABLE (MODEL 210078M). THE DEVICES ARE INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
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