Approval for changes in the primary packaging of bulkamid urethral bulking system (bulkamid rotatable sheath), upgrade to the corresponding process equipment, and replacement of the pouch sealing machine
| Device | Bulkamid Urethral Bulking System |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Contura International A/S |
| Date Received | 2020-08-13 |
| Decision Date | 2020-10-22 |
| PMA | P170023 |
| Supplement | S003 |
| 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