XACT CAROTID STENT SYSTEM
FDA premarket approval P040038/S008 · decided 2007-01-19
Approval details
- PMA number
- P040038
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- XACT CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2006-12-18
- Decision date
- 2007-01-19
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PROCESSES AND COMPONENTS USED TO MANUFACTURE THE STENT DELIVERY SYSTEM HANDLE.
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