Note: 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. |
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Device | i-FACTOR Peptide Enhanced Bone Graft |
Generic Name | Filler, bone void, synthetic peptide |
Applicant | CERAPEDICS, LLC 11025 DOVER STREET SUITE 1600 WESTMINSTER, CO 80021 |
PMA Number | P140019 |
Supplement Number | S004 |
Date Received | 06/15/2020 |
Decision Date | 07/22/2020 |
Product Code |
NOX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updated labeling to include the results from the completed 72-month follow-up post-approval study. |
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