EXPRESS SD RENAL PREMOUNTED STENT SYSTEM
FDA premarket approval P060006/S001 · decided 2009-12-04
Approval details
- PMA number
- P060006
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS SD RENAL PREMOUNTED STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Boston Scientific Corp
- Date received
- 2009-11-05
- Decision date
- 2009-12-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- ADDITION OF AN ANALYTICAL TEST METHOD.
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|---|---|---|
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