NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEM
FDA premarket approval P980001/S017 · decided 2000-08-03
Approval details
- PMA number
- P980001
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEM
- Applicant
- Boston Scientific Corp
- Date received
- 2000-02-23
- Decision date
- 2000-08-03
- Days to decision
- 162 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- APPROVAL FOR THE NIROYAL(TM) ELITE PROMOUNTED STENT SYSTEMS. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: *PATIENTS WITH SYMOPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM; * TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED IN TERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND * PATIENTS WITH SYMP
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