PMA P040012S037
- Device
- ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S037
- Product code
- NIM
- Decision date
- 2011-03-30
- Generic name
- Stent, carotid
- Approval order statement
- CHANGES TO THE IN- PROCESS INSPECTION AND SPECIFICATION FOR THE INNER MEMBER (IM) TO HYPOTUBE BOND OF THE ACCULINK CAROTID STENT SYSTEM.
Current openFDA PMA Record#
- Device
- ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S037
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2011-03-30
- Decision code
- OK30
- Date received
- 2011-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE IN- PROCESS INSPECTION AND SPECIFICATION FOR THE INNER MEMBER (IM) TO HYPOTUBE BOND OF THE ACCULINK CAROTID STENT SYSTEM.