NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM
FDA premarket approval P050025/S003 · decided 2007-05-10
Approval details
- PMA number
- P050025
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific
- Date received
- 2007-04-12
- Decision date
- 2007-05-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- ADDITION OF AN INSPECTION PROCEDURE AND A NEW VISUAL STANDARD THAT WILL BE IMPLEMENTED AS PART OF ROUTINE RECEIVING AND INSPECTION FOR A SUBASSEMBLY USED WITH THE NEXSTENT CAROTID STENT SYSTEM.
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