PMA P210020S004
- Device
- Optilume Urethral Drug Coated Balloon
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S004
- Product code
- QRH
- Decision date
- 2022-05-17
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Approval order statement
- Approval for validation of a new Low EO sterilization cycle utilizing a lower ethylene oxide (EO) concentration and lower EO dwell time.
Current openFDA PMA Record#
- Device
- Optilume Urethral Drug Coated Balloon
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S004
- Product code
- QRH
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Decision date
- 2022-05-17
- Decision code
- APPR
- Date received
- 2022-02-24
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for validation of a new Low EO sterilization cycle utilizing a lower ethylene oxide (EO) concentration and lower EO dwell time.