PMA P040012S056
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S056
- Product code
- NIM
- Decision date
- 2016-03-04
- Generic name
- Stent, carotid
- Approval order statement
- Approval of the following changes to the post-approval study for the device:request to modify the conditions of approval follow-up requirement from 3 to 2 years.
Current openFDA PMA Record#
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S056
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2016-03-04
- Decision code
- APPR
- Date received
- 2016-01-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the following changes to the post-approval study for the device:request to modify the conditions of approval follow-up requirement from 3 to 2 years.