PMA P040012S044
- Device
- RX ACCULINK CARTOID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S044
- Product code
- NIM
- Decision date
- 2012-08-24
- Generic name
- Stent, carotid
- Approval order statement
- APPROVAL TO UPDATE THE LABELING WITH LONG TERM CREST STUDY RESULTS.
Current openFDA PMA Record#
- Device
- RX ACCULINK CARTOID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S044
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2012-08-24
- Decision code
- APPR
- Date received
- 2012-03-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO UPDATE THE LABELING WITH LONG TERM CREST STUDY RESULTS.