PMA P040012S058
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S058
- Product code
- NIM
- Decision date
- 2016-12-23
- Generic name
- Stent, carotid
- Approval order statement
- Approval for updates to the MR Conditional label.
Current openFDA PMA Record#
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S058
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2016-12-23
- Decision code
- APPR
- Date received
- 2016-10-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the MR Conditional label.