NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
FDA premarket approval P980001 · decided 1998-08-11
Approval details
- PMA number
- P980001
- Trade name
- NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Boston Scientific Corp
- Date received
- 1998-01-28
- Decision date
- 1998-08-11
- Days to decision
- 195 days
- Decision code
- APWD
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- approval for the NIR ON(TM) Ranger(TM) and NIR ON(TM) Ranger(TM) w/SOX(TM) Premounted Stent Systems. The device is indicated for improving coronary luminal diamter in the following patient subsets: a)patients with symptomatic 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; b) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in
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