PMA P220029S002

Device: Optilume™ BPH Catheter System
Applicant: Urotronic, Inc.
PMA number: P220029
Supplement: S002
Product code: QXB
Decision date: 2024-08-15
Classification: Gastroenterology, Urology
Generic name: Drug coated prostatic dilation catheter for benign prostatic hyperplasia
Approval order statement: approval for a change in supplier for two kit components (i.e., the Tuohy-Borst adapter and stopcock), a change in kit packaging of the components (i.e., addition of the Tuohy-Borst adapter and Stopcock to the Pre-Dilation Catheter Tyvek Pouch), and a change in labeling to remove the vascular meta-analysis information from the Instructions for Use

Current openFDA PMA Record#

Device: Optilume™ BPH Catheter System
Applicant: Urotronic, Inc.
PMA number: P220029
Supplement: S002
Product code: QXB
Generic name: Drug coated prostatic dilation catheter for benign prostatic hyperplasia
Decision date: 2024-08-15
Decision code: APPR
Date received: 2024-05-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a change in supplier for two kit components (i.e., the Tuohy-Borst adapter and stopcock), a change in kit packaging of the components (i.e., addition of the Tuohy-Borst adapter and Stopcock to the Pre-Dilation Catheter Tyvek Pouch), and a change in labeling to remove the vascular meta-analysis information from the Instructions for Use