NEXSTENT STENT AND MONORAIL DELIVERY SYSTEM
FDA premarket approval P050025/S005 · decided 2007-08-17
Approval details
- PMA number
- P050025
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEXSTENT STENT AND MONORAIL DELIVERY SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific
- Date received
- 2007-07-19
- Decision date
- 2007-08-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- ADDITION OF A SECOND ETO STERILIZATION CHAMBER AT THE STERIGENICS WILLOWBROOK (WB) STERILIZATION FACILITY.
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