PMA P040012S057
- Device
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S057
- Product code
- NIM
- Decision date
- 2017-01-05
- Generic name
- Stent, carotid
- Approval order statement
- Approval for the addition of the CANOPY Post-Approval Study (PAS) results to the Instructions for Use (IFU).
Current openFDA PMA Record#
- Device
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S057
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2017-01-05
- Decision code
- APPR
- Date received
- 2016-09-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of the CANOPY Post-Approval Study (PAS) results to the Instructions for Use (IFU).