PMA P240029S002
- Device
- CGuard™ Prime Carotid Stent System
- Applicant
- InspireMD, Ltd.
- PMA number
- P240029
- Supplement
- S002
- Product code
- NIM
- Decision date
- 2026-03-16
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- the introduction of an additional stent crimper
Current openFDA PMA Record#
- Device
- CGuard™ Prime Carotid Stent System
- Applicant
- InspireMD, Ltd.
- PMA number
- P240029
- Supplement
- S002
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-03-16
- Decision code
- OK30
- Date received
- 2026-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of an additional stent crimper