PMA P040012S004
- Device
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S004
- Product code
- NIM
- Decision date
- 2006-03-24
- Generic name
- Stent, carotid
- Approval order statement
- REDUCING SAMPLING AQL FOR STRAIN RELIEF COMPONENT DIMENSIONAL INSPECTION.
Current openFDA PMA Record#
- Device
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S004
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2006-03-24
- Decision code
- OK30
- Date received
- 2006-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCING SAMPLING AQL FOR STRAIN RELIEF COMPONENT DIMENSIONAL INSPECTION.