FDA-Device2017-01-11Class II
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require
Tepha Incorporated
Hazard
Endotoxin values from testing of retains slightly exceeded the established specification.
Sold states
Nationwide Distribution to IN, CA, FL, MI, NV, and MT
Affected count
29
Manufactured in
99 Hayden Ave Ste 360, N/A, Lexington, MA, United States
Products
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0948-2017Don't want to check this manually?
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