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.
Approval for an alternate secondary packaging configuration for augment injectable and corresponding changes in the augment injectable package insert and surgical technique guide reflecting this alternate packaging configuration; re-design of the augment injectable kit carton to accommodate a pouch in pouch configuration; and modifications to the payload area and the number of frozen gel packs utilized in the approved shipping unit for both augment injectable and augment bone graft.
| Device | AUGMENT Bone Graft and AUGMENT Injectable |
| Classification Name | Filler, Bone Void, Synthetic Peptide |
| Generic Name | Filler, Bone Void, Synthetic Peptide |
| Applicant | BIOMIMETIC THERAPEUTICS,LLC |
| Date Received | 2018-07-02 |
| Decision Date | 2018-09-26 |
| PMA | P100006 |
| Supplement | S006 |
| Product Code | NOX |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BIOMIMETIC THERAPEUTICS,LLC 389 Nichol Mill Ln franklin, TN 37067 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100006 | Original Filing | |
| S013 | 2021-12-15 | Normal 180 Day Track No User Fee |
| S012 | 2021-09-09 | Real-time Process |
| S011 | 2019-11-07 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | 2019-04-11 | Normal 180 Day Track |
| S008 | 2018-10-23 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2018-07-02 | Real-time Process |
| S005 | 2016-10-31 | Panel Track |
| S004 | 2016-03-21 | Normal 180 Day Track No User Fee |
| S003 | 2015-09-30 | Normal 180 Day Track No User Fee |
| S002 | 2015-09-30 | Normal 180 Day Track No User Fee |
| S001 | 2015-09-28 | Real-time Process |