PMA P040038S039
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S039
- Product code
- NIM
- Decision date
- 2021-12-08
- Generic name
- Stent, carotid
- Approval order statement
- Supplier and manufacturing changes to the Exit Port Molding (EPM) component of the XACT Carotid Stent System.
Current openFDA PMA Record#
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S039
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2021-12-08
- Decision code
- OK30
- Date received
- 2021-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier and manufacturing changes to the Exit Port Molding (EPM) component of the XACT Carotid Stent System.