Approval for minor changes to the bulkamid needle, including a change in the manufacturer for the bulkamid needle, which includes minor changes to the needle hub’s outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch
| Device | Bulkamid Urethral Bulking System |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Contura International A/S |
| Date Received | 2020-09-04 |
| Decision Date | 2020-12-02 |
| PMA | P170023 |
| Supplement | S005 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Contura International A/S sydmarken 23 soeborg 2860 |
Supplemental Filings
| 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 |
NIH GUDID Devices