Optilume Urethral Drug Coated Balloon

FDA Premarket Approval P210020 S005

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

DeviceOptilume Urethral Drug Coated Balloon
Generic NameCatheter, Balloon, Urethral, Drug-coated
ApplicantUrotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS005 Date Received05/12/2022 Decision Date06/10/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-05-12
Decision Date2022-06-10
PMAP210020
SupplementS005
Product CodeQRH 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductYes
Applicant AddressUrotronic, Inc.
2495 Xenium Lane
minneapolis, MN 55441 PMA NumberP210020 Supplement NumberS005 Date Received05/12/2022 Decision Date06/10/2022 Product Code QRH  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductYes Approval Order Statement  
approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P210020.

Supplemental Filings

Supplement NumberDateSupplement Type
P210020Original Filing
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

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