PMA P210020S010

Device: Optilume Urethral Drug Coated Balloon Catheter
Applicant: Urotronic, Inc.
PMA number: P210020
Supplement: S010
Product code: QRH
Decision date: 2025-06-23
Classification: Gastroenterology, Urology
Generic name: Catheter, Balloon, Urethral, Drug-Coated
Approval order statement: approval for packaging the Optilume Urethral DCB with the Optilume Basic Urological Balloon Dilation Catheter and Atrion Medical QL inflation device into a kit, an additional site to package the proposed kit, and a labeling change to remove the vascular meta-analysis information from the Instruction for Use.

Current openFDA PMA Record#

Device: Optilume Urethral Drug Coated Balloon Catheter
Applicant: Urotronic, Inc.
PMA number: P210020
Supplement: S010
Product code: QRH
Generic name: Catheter, Balloon, Urethral, Drug-Coated
Decision date: 2025-06-23
Decision code: APPR
Date received: 2024-12-16
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for packaging the Optilume Urethral DCB with the Optilume Basic Urological Balloon Dilation Catheter and Atrion Medical QL inflation device into a kit, an additional site to package the proposed kit, and a labeling change to remove the vascular meta-analysis information from the Instruction for Use.