PMA P210025S006
- Device
- SurVeil Drug-Coated Balloon
- Applicant
- Surmodics,Inc.
- PMA number
- P210025
- Supplement
- S006
- Product code
- ONU
- Decision date
- 2025-06-06
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- inclusion of final post-approval study data in the labeling.
Current openFDA PMA Record#
- Device
- SurVeil Drug-Coated Balloon
- Applicant
- Surmodics,Inc.
- PMA number
- P210025
- Supplement
- S006
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2025-06-06
- Decision code
- APPR
- Date received
- 2025-02-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- inclusion of final post-approval study data in the labeling.