PMA P210025S005
- Device
- Surmodics SurVeil™ Drug-Coated Balloon
- Applicant
- Surmodics,Inc.
- PMA number
- P210025
- Supplement
- S005
- Product code
- ONU
- Decision date
- 2024-12-20
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- a change to the in-process specification criteria for the balloon base coat solution
Current openFDA PMA Record#
- Device
- Surmodics SurVeil™ Drug-Coated Balloon
- Applicant
- Surmodics,Inc.
- PMA number
- P210025
- Supplement
- S005
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2024-12-20
- Decision code
- OK30
- Date received
- 2024-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the in-process specification criteria for the balloon base coat solution