PMA P220029S004
- Device
- Optilume™ BPH Catheter System
- Applicant
- Urotronic, Inc.
- PMA number
- P220029
- Supplement
- S004
- Product code
- QXB
- Decision date
- 2025-12-12
- Classification
- Gastroenterology, Urology
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Approval order statement
- a change of an additional pre-dilation catheter supplier manufacturing site
Current openFDA PMA Record#
- Device
- Optilume™ BPH Catheter System
- Applicant
- Urotronic, Inc.
- PMA number
- P220029
- Supplement
- S004
- Product code
- QXB
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Decision date
- 2025-12-12
- Decision code
- OK30
- Date received
- 2025-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change of an additional pre-dilation catheter supplier manufacturing site