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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device in situ polymerizing peripheral nerve cap
Definition An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma.
Product CodeSBG
Regulation Number 882.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
TULAVI THERAPEUTICS
  GRANTED 1
TULAVI THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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