PMA P210030
- Device
- Roadsaver/CASPER Carotid Stent Device
- Applicant
- MicroVention, Inc.
- PMA number
- P210030
- Supplement
- S001
- Product code
- NIM
- Decision date
- 2025-06-23
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- Approval for post-approval labeling update to include the CONFIDENCE study results through 3 years of follow-up
Current openFDA PMA Record
- Device
- Roadsaver/CASPER Carotid Stent Device
- Applicant
- MicroVention, Inc.
- PMA number
- P210030
- Supplement
- S001
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-06-23
- Decision code
- APPR
- Date received
- 2025-02-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for post-approval labeling update to include the CONFIDENCE study results through 3 years of follow-up