PMA P040012
- Device
- RX Acculink
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S064
- Product code
- NIM
- Decision date
- 2025-10-22
- Generic name
- Stent, carotid
- Approval order statement
- approval for a change to the sponge used during the catheter lubricious coating application process
Current openFDA PMA Record#
- Device
- RX Acculink
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S066
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-10-22
- Decision code
- OK30
- Date received
- 2025-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change to the sponge used during the catheter lubricious coating application process