FDA.reportPublic FDA data

BIONOVA MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099733233009973323BIONOVA MEDICAL, INC.1N2026-01-013012 CENTRE OAK WAY STE 102 Germantown TN US 38138

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1489521107302576K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloFRO2024-10-31
1489521217920841K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoFRO2024-08-21
1489521300619059K231937Foundation Dermal Regeneration Scaffold (DRS) SoloKGN2023-11-13
1489521227908365K123961SENTREX BIOSPONGE MPDKGN2013-04-05
1489521343196430K112191HEALEX BIOSPONGE WOUND DRESSINGKGN2012-06-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN32023-11-13
FRO22024-10-31

PMN#