STINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE
FDA premarket approval P000020/S001 · decided 2001-05-18
Approval details
- PMA number
- P000020
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2001-01-08
- Decision date
- 2001-05-18
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lowell, MA
- Statement
- APPROVAL FOR A CHANGE TO THE MATERIALS OF THE CATHETER TIP TO INCREASE ITS STIFFNESS AND OTHER MINOR DEVICE MODIFICATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STIN S ABLATION CATHETER AND 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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