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 an alternate cold chain shipping unit, the aerosafe a50 13l shipper, in addition to the current u39 shipper utilized for augment bone graft and augment injectable.
| Device | AUGMENT Bone Graft and AUGMENT Injectable |
| Generic Name | Filler, Bone Void, Synthetic Peptide |
| Applicant | BIOMIMETIC THERAPEUTICS,LLC |
| Date Received | 2021-09-09 |
| Decision Date | 2021-11-17 |
| PMA | P100006 |
| Supplement | S012 |
| Product Code | NOX |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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 |