ENDOTEX NEXSTENT CAROTID STENT AND MONORAIL
FDA premarket approval P050025/S002 · decided 2007-04-10
Approval details
- PMA number
- P050025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ENDOTEX NEXSTENT CAROTID STENT AND MONORAIL
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific
- Date received
- 2007-03-07
- Decision date
- 2007-04-10
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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