STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
FDA premarket approval P000020 · decided 2000-11-29
Approval details
- PMA number
- P000020
- Trade name
- STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2000-05-04
- Decision date
- 2000-11-29
- Days to decision
- 209 days
- Decision code
- APWD
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lowell, MA
- Statement
- APPROVAL FOR THE STINGER(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE. THE DEVICE IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
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