PMA P220029
- Device
- Optilume™ BPH Catheter System
- Applicant
- Urotronic, Inc.
- Product code
- QXB
- Decision date
- 2025-12-15
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS)
Current openFDA PMA Record#
- Device
- Optilume™ BPH Catheter System
- Applicant
- Urotronic, Inc.
- PMA number
- P220029
- Supplement
- S003
- Product code
- QXB
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Decision date
- 2025-12-15
- Decision code
- APPR
- Date received
- 2025-11-17
- 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)