PMA P040012S055
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S055
- Product code
- NIM
- Decision date
- 2015-04-02
- Generic name
- Stent, carotid
- Approval order statement
- ALTERNATE SUPPLIER FOR THE NOTCHED HYPOTUBE OF THE STENT DELIVERY SYSTEM AND ASSOCIATED CHANGES TO THE INSPECTION AND PROCESS MONITORING FOR THIS COMPONENT.
Current openFDA PMA Record#
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S055
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2015-04-02
- Decision code
- OK30
- Date received
- 2015-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER FOR THE NOTCHED HYPOTUBE OF THE STENT DELIVERY SYSTEM AND ASSOCIATED CHANGES TO THE INSPECTION AND PROCESS MONITORING FOR THIS COMPONENT.