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.
Device | Bulkamid Urethral Bulking System |
Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
Applicant | Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS010 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-07-08 |
Decision Date | 2022-08-05 |
PMA | P170023 |
Supplement | S010 |
Product Code | LNM |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618 PMA NumberP170023 Supplement NumberS010 Date Received07/08/2022 Decision Date08/05/2022 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 approval Of An Alternate Sub-supplier Of A Raw Material |
Supplement Number | Date | Supplement Type |
---|---|---|
P170023 | Original 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 |
Device ID | PMA | Supp |
---|---|---|
05704101500500 | P170023 | 000 |
10810005340493 | P170023 | 015 |