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 use of lot uv0023 of the drug substance rhpdgf-bb manufactured by novartis to be used in the manufacture of the drug product used in augment bone graft and augment injectable.
| 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 | 2019-04-11 |
| Decision Date | 2019-09-11 |
| PMA | P100006 |
| Supplement | S009 |
| Product Code | NOX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |