NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS
FDA premarket approval P980001/S024 · decided 2001-02-16
Approval details
- PMA number
- P980001
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- Date received
- 2000-08-03
- Decision date
- 2001-02-16
- Days to decision
- 197 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- APPROVAL FOR THE NIR(TM) ELITE MONORAIL AND OTW STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <=25 MM) IN REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM; 2) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND 3) PATIENTS WITH SY
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510(k) clearances by this applicant
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