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U.S. Department of Health and Human Services

Product Classification

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Device filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Definition Pma approved: p000054.
Review Panel Physical Medicine
Product CodeMPW
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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