NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
FDA premarket approval P050025/S008 · decided 2008-04-09
Approval details
- PMA number
- P050025
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific
- Date received
- 2008-03-10
- Decision date
- 2008-04-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE ESTABLISHMENT OF A NEW TEST TO THE INSPECTION OF INCOMING SUBASSEMBLIES.
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