PMA P040038S051
- Device
- XACT™ Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S051
- Product code
- NIM
- Decision date
- 2026-03-20
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- approval of a modified sterilization cycle at chamber C, 7, and 8 at Sterigenics Los Angeles and chamber 2 and 3 at Sterigenics Costa Rica
Current openFDA PMA Record#
- Device
- XACT™ Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S051
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-03-20
- Decision code
- OK30
- Date received
- 2026-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a modified sterilization cycle at chamber C, 7, and 8 at Sterigenics Los Angeles and chamber 2 and 3 at Sterigenics Costa Rica