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. |
|
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 | S003 |
Date Received | 04/17/2019 |
Decision Date | 10/11/2019 |
Product Code |
NOX |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00310440
|
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 an updated package insert that incorporates the 24-month follow-up data from all subjects enrolled in the original clinical study. |
|
|