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 NumberS011 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 | S011 |
| 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 NumberS011 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 Manufacturing 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 |