PMA P210020S005
- Device
- Optilume Urethral Drug Coated Balloon
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S005
- Product code
- QRH
- Decision date
- 2022-06-10
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Optilume Urethral Drug Coated Balloon
- Applicant
- Urotronic, Inc.
- PMA number
- P210020
- Supplement
- S005
- Product code
- QRH
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Decision date
- 2022-06-10
- Decision code
- APPR
- Date received
- 2022-05-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.