PMA P220029S001
- Device
- Optilume™ BPH Catheter System
- Applicant
- Urotronic, Inc.
- PMA number
- P220029
- Supplement
- S001
- Product code
- QXB
- Decision date
- 2023-08-25
- Classification
- Gastroenterology, Urology
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Optilume™ BPH Catheter System
- Applicant
- Urotronic, Inc.
- PMA number
- P220029
- Supplement
- S001
- Product code
- QXB
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Decision date
- 2023-08-25
- Decision code
- APPR
- Date received
- 2023-07-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.