RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
FDA premarket approval P040012/S009 · decided 2006-07-18
Approval details
- PMA number
- P040012
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2006-02-28
- Decision date
- 2006-07-18
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A MODIFICATION TO A MANUFACTURING PROCESS TO IMPROVE WICKING OF GLUE BETWEEN THE HYPOTUBE AND THE INNER MEMBER AND A MODIFICATION TO THE LOT HISTORY RECORD BILL OF MATERIALS TO ADD A NEW BLOCK FOR DOCUMENTING THE NEW PROCESS.
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