PMA P040038S036
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S036
- Product code
- NIM
- Decision date
- 2020-09-03
- Generic name
- Stent, carotid
- Approval order statement
- Changes to the suppliers of plastic injection molded components.
Current openFDA PMA Record#
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S036
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2020-09-03
- Decision code
- OK30
- Date received
- 2020-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the suppliers of plastic injection molded components.