Optilume Urethral Drug Coated Balloon

FDA Premarket Approval P210020 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the protocol for the post-approval study (pas) referenced above.

• Device: Optilume Urethral Drug Coated Balloon
• Generic Name: Catheter, Balloon, Urethral, Drug-coated
• Applicant: Urotronic, Inc.
• Date Received: 2021-12-28
• Decision Date: 2022-01-27
• PMA: P210020
• Supplement: S002
• Product Code: QRH
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Urotronic, Inc. 2495 Xenium Lane minneapolis, MN 55441

Supplemental Filings

Supplement Number	Date	Supplement Type
P210020		Original Filing
S006	2022-08-30	Normal 180 Day Track No User Fee
S005	2022-05-12	Normal 180 Day Track No User Fee
S004	2022-02-24	Real-time Process
S003	2022-01-05	Normal 180 Day Track No User Fee
S002	2021-12-28	Normal 180 Day Track No User Fee
S001	2021-12-20	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
00853095008334	P210020	000
00853095008327	P210020	000
00853095008310	P210020	000
00853095008303	P210020	000
00853095008297	P210020	000
00853095008280	P210020	000
00853095008273	P210020	000
00853095008242	P210020	000