PMA P040012S016
- Device
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S016
- Product code
- NIM
- Decision date
- 2006-07-11
- Generic name
- Stent, carotid
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING PRINTING AND INSPECTION PROCEDURES.
Current openFDA PMA Record#
- Device
- RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S016
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2006-07-11
- Decision code
- APPR
- Date received
- 2006-06-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING PRINTING AND INSPECTION PROCEDURES.