PMA P040012S028
- Device
- ACCULINK CAROTID STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S028
- Product code
- NIM
- Decision date
- 2008-12-10
- Generic name
- Stent, carotid
- Approval order statement
- MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
Current openFDA PMA Record#
- Device
- ACCULINK CAROTID STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S028
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2008-12-10
- Decision code
- OK30
- Date received
- 2008-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.