NIR ON RANGER AND NIR ON RANGER WITH/SOX
FDA premarket approval P980001/S004 · decided 1999-03-10
Approval details
- PMA number
- P980001
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NIR ON RANGER AND NIR ON RANGER WITH/SOX
- Applicant
- Boston Scientific Corp
- Date received
- 1999-02-09
- Decision date
- 1999-03-10
- Days to decision
- 29 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- Approval for a change in the specification of the balloon component for the NIR ON(TM) Ranger(TM) Premounted Stent System. This change applies only to the 9 mm length NIR ON(TM) Ranger(TM) Premounted Stent System with the 3.0mm, 3.5mm and 4.0mm balloon diameters.
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