PMA P040012S062
- Device
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S062
- Product code
- NIM
- Decision date
- 2021-10-12
- Generic name
- Stent, carotid
- Approval order statement
- Manufacturing site change for a hypotube supplier.
Current openFDA PMA Record#
- Device
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S062
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2021-10-12
- Decision code
- OK30
- Date received
- 2021-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site change for a hypotube supplier.