Approval for the removal of testing of heavy metals in raw materials for durolane as per usp and replacing it by a risk analysis on the final product based on ich q3d guideline for elemental impurities.
| Device | DUROLANE |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Bioventus LLC |
| Date Received | 2020-04-29 |
| Decision Date | 2020-10-08 |
| PMA | P170007 |
| Supplement | S006 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bioventus LLC 4721 Emperor Blvd, Suite 100 durham, NC 27703 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170007 | | Original Filing |
| S014 |
2022-09-14 |
30-day Notice |
| S013 |
2022-02-03 |
30-day Notice |
| S012 |
2022-02-03 |
30-day Notice |
| S011 |
2022-01-06 |
30-day Notice |
| S010 |
2021-08-04 |
30-day Notice |
| S009 |
2021-04-28 |
30-day Notice |
| S008 |
2020-09-23 |
30-day Notice |
| S007 |
2020-09-01 |
Normal 180 Day Track |
| S006 |
2020-04-29 |
Real-time Process |
| S005 |
2019-11-18 |
30-day Notice |
| S004 |
2019-08-20 |
30-day Notice |
| S003 |
2019-05-09 |
30-day Notice |
| S002 |
2019-02-06 |
30-day Notice |
| S001 |
2018-07-19 |
30-day Notice |
NIH GUDID Devices