PMA P040012S053
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S053
- Product code
- NIM
- Decision date
- 2014-06-05
- Generic name
- Stent, carotid
- Approval order statement
- APPROVAL FOR A CHANGE IN THE VISUAL INSPECTION CRITERIA FOR BENT STRUTS FOR THE RX ACCULINK CAROTID STENT SYSTEM.
Current openFDA PMA Record#
- Device
- RX ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S053
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2014-06-05
- Decision code
- APPR
- Date received
- 2013-11-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE VISUAL INSPECTION CRITERIA FOR BENT STRUTS FOR THE RX ACCULINK CAROTID STENT SYSTEM.