NIR(R) PREMOUNTED STENT SYSTEM
FDA premarket approval P980001/S033 · decided 2001-06-07
Approval details
- PMA number
- P980001
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NIR(R) PREMOUNTED STENT SYSTEM
- Applicant
- Boston Scientific Corp
- Date received
- 2001-05-16
- Decision date
- 2001-06-07
- Days to decision
- 22 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Natick,, MA
- Statement
- CHANGE IN THE ACCEPTANCE CRITERIA FOR AN IN-PROCESS INSPECTION STEP FOR THE BALLOON COMPONENT USED IN THE MANUFACTURE OF THE NIR(R) PREMOUNTED STENT SYSTEMS.
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|---|---|---|
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