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 | Durolane |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS013 Date Received02/03/2022 Decision Date03/03/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-03 |
| Decision Date | 2022-03-03 |
| PMA | P170007 |
| Supplement | S013 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bioventus LLC 4721 Emperor Blvd, Suite 100 durham, NC 27703 PMA NumberP170007 Supplement NumberS013 Date Received02/03/2022 Decision Date03/03/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of An Alternative Supplier For Sodium Hydroxide And Hydrochloric Acid Solutions Used In The Manufacturing Of DUROLANE |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00816986020808 | P170007 | 000 |
| 08437027710001 | P170007 | 000 |
| 05060548950071 | P170007 | 001 |