Bulkamid Urethral Bulking System

FDA Premarket Approval P170023 S012

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

DeviceBulkamid Urethral Bulking System
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantAxonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-27
Decision Date2022-10-26
PMAP170023
SupplementS012
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAxonics Modulation Technologies, Inc.
26 Technology Drive
irvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Alternate Sub-supplier Of A Manufacturing Raw Material

Supplemental Filings

Supplement NumberDateSupplement Type
P170023Original Filing
S013 2022-09-27 30-day Notice
S012 2022-09-27 30-day Notice
S011 2022-07-08 30-day Notice
S010 2022-07-08 30-day Notice
S009 2022-07-08 30-day Notice
S008 2020-12-18 30-day Notice
S007 2020-11-24 30-day Notice
S006
S005 2020-09-04 Real-time Process
S004
S003 2020-08-13 Real-time Process
S002
S001 2020-05-05 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05704101500500 P170023 000

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