PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant

  • Model / Serial
    Lot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) including the Virgin Islands and South Africa.
  • Product Description
    PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
  • Manufacturer Parent Company (2017)
  • Source
    USFDA