PMA P040038S038
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S038
- Product code
- NIM
- Decision date
- 2021-11-24
- Generic name
- Stent, carotid
- Approval order statement
- Modifications to the equipment and processes used for laser cutting, microblasting, electropolishing, and cleaning of the stent subcomponent.
Current openFDA PMA Record#
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S038
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2021-11-24
- Decision code
- OK30
- Date received
- 2021-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the equipment and processes used for laser cutting, microblasting, electropolishing, and cleaning of the stent subcomponent.