RX ACCULINK/ACCULINK CAROTID STENT SYSTEM
FDA premarket approval P040012/S030 · decided 2009-08-05
Approval details
- PMA number
- P040012
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RX ACCULINK/ACCULINK CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular
- Date received
- 2009-07-06
- Decision date
- 2009-08-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- EXPANSION OF THE ACCULINK MANUFACTURING PROCESSES WITHIN THE EXISTING MANUFACTURING FACILITY IN TEMECULA, CALIFORNIA.
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