PMA P040038S050
- Device
- XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS)
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S050
- Product code
- NIM
- Decision date
- 2025-10-17
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- an alternate adhesive for a non-patient contacting bond in the handle assembly
Current openFDA PMA Record#
- Device
- XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS)
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S050
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-10-17
- Decision code
- OK30
- Date received
- 2025-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate adhesive for a non-patient contacting bond in the handle assembly