PMA P040012S050
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S050
- Product code
- NIM
- Decision date
- 2012-12-19
- Generic name
- Stent, carotid
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE RX ACCULINK CAROTID STENT SYSTEMS BONDING OF THE INNER MEMBER, GUIDEWIRE LUMEN AND NOTCHED HYPOTUBE.
Current openFDA PMA Record#
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S050
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2012-12-19
- Decision code
- APPR
- Date received
- 2012-10-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE RX ACCULINK CAROTID STENT SYSTEMS BONDING OF THE INNER MEMBER, GUIDEWIRE LUMEN AND NOTCHED HYPOTUBE.