PMA P040012S015
- Device
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S015
- Product code
- NIM
- Decision date
- 2006-06-26
- Generic name
- Stent, carotid
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE LOT HISTORY BILL OF MATERIALS TO REMOVE SPECIFIED QUALITY AUDITS THAT ARE NOT NECESSARY OR VALUE ADDED.
Current openFDA PMA Record#
- Device
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S015
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2006-06-26
- Decision code
- APPR
- Date received
- 2006-03-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE LOT HISTORY BILL OF MATERIALS TO REMOVE SPECIFIED QUALITY AUDITS THAT ARE NOT NECESSARY OR VALUE ADDED.