Aventamed Dac FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))510(k)Apr 28, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Apr 28, 2025
Solo+ Tympanostomy Tube Device (TTD)510(k)May 20, 2024Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 20, 2024