PMA P210020S009
- Device
- Optilume Urethral Drug Coated Balloon catheter
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S009
- Product code
- QRH
- Decision date
- 2024-01-13
- Classification
- Gastroenterology, Urology
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Approval order statement
- to implement an additional Confluent Medical catheter manufacturing site in Costa Rica
Current openFDA PMA Record#
- Device
- Optilume Urethral Drug Coated Balloon catheter
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S009
- Product code
- QRH
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Decision date
- 2024-01-13
- Decision code
- OK30
- Date received
- 2023-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement an additional Confluent Medical catheter manufacturing site in Costa Rica