EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
FDA premarket approval P060006/S006 · decided 2010-05-28
Approval details
- PMA number
- P060006
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Boston Scientific Corp
- Date received
- 2010-01-27
- Decision date
- 2010-05-28
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR REINSTATEMENT OF A SECONDARY STERILIZATION SITE FORMERLY OWNED BY STERIS ISOMEDIX SERVICES, INC. (STERIS) LOCATED IN COVENTRY, RHODE ISLAND.
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