|
Device | Optilume™ BPH Catheter System |
Generic Name | Drug coated prostatic dilation catheter for benign prostatic hyperplasia |
Applicant | Urotronic, Inc 2495 Xenium Lane Minneapolis, MN 55449 |
PMA Number | P220029 |
Supplement Number | S001 |
Date Received | 07/27/2023 |
Decision Date | 08/25/2023 |
Product Code |
QXB |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) protocol. |