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 | Augment® Bone Graft |
| Generic Name | Filler, Bone Void, Synthetic Peptide |
| Applicant | BIOMIMETIC THERAPEUTICS,LLC389 Nichol Mill Lnfranklin, TN 37067 PMA NumberP100006 Supplement NumberS013 Date Received12/15/2021 Decision Date06/13/2022 Product Code NOX Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-06-13 |
| PMA | P100006 |
| Supplement | S013 |
| Product Code | NOX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BIOMIMETIC THERAPEUTICS,LLC 389 Nichol Mill Ln franklin, TN 37067 PMA NumberP100006 Supplement NumberS013 Date Received12/15/2021 Decision Date06/13/2022 Product Code NOX Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For A Modified Package Insert Incorporating Updated Clinical Data Based On Completion Of The Postapproval Clinical Study. |
| 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 |