PMA P210020S008
- Device
- Optilume Urethral Drug Coated Balloon
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S008
- Product code
- QRH
- Decision date
- 2023-04-25
- Classification
- Gastroenterology, Urology
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Approval order statement
- Changes to balloon catheter hub bonding process, acceptable quality level for receiving inspection, and leak test maximum delivered pressure.
Current openFDA PMA Record#
- Device
- Optilume Urethral Drug Coated Balloon
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S008
- Product code
- QRH
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Decision date
- 2023-04-25
- Decision code
- OK30
- Date received
- 2023-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to balloon catheter hub bonding process, acceptable quality level for receiving inspection, and leak test maximum delivered pressure.