PMA P040012S030
- Device
- RX ACCULINK/ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S030
- Product code
- NIM
- Decision date
- 2009-08-05
- Generic name
- Stent, carotid
- Approval order statement
- EXPANSION OF THE ACCULINK MANUFACTURING PROCESSES WITHIN THE EXISTING MANUFACTURING FACILITY IN TEMECULA, CALIFORNIA.
Current openFDA PMA Record#
- Device
- RX ACCULINK/ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S030
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2009-08-05
- Decision code
- OK30
- Date received
- 2009-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXPANSION OF THE ACCULINK MANUFACTURING PROCESSES WITHIN THE EXISTING MANUFACTURING FACILITY IN TEMECULA, CALIFORNIA.