PMA P040038S049
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S049
- Product code
- NIM
- Decision date
- 2025-08-25
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- to transfer delivery system component manufacturing to in-house and for minor changes to raw material specifications
Current openFDA PMA Record#
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S049
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-08-25
- Decision code
- OK30
- Date received
- 2025-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to transfer delivery system component manufacturing to in-house and for minor changes to raw material specifications