PMA P040012S059
- Device
- Rx Acculink Carotid Stent System
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S059
- Product code
- NIM
- Decision date
- 2017-04-07
- Generic name
- Stent, carotid
- Approval order statement
- Change to the frequency of routine bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- Rx Acculink Carotid Stent System
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S059
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2017-04-07
- Decision code
- OK30
- Date received
- 2017-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the frequency of routine bacterial endotoxin testing.