Polynovo Biomaterials Pty, Ltd. FDA Approvals

0 new drug approvals and 3 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
NovoSorb BTM510(k)Jun 20, 2025	—	510(k)Substantially Equivalent (Special)	Jun 20, 2025
NovoSorb® MTX510(k)Mar 5, 2025	—	510(k)Substantially Equivalent (Traditional)	Mar 5, 2025
NovoSorb Matrix510(k)Sep 15, 2022	—	510(k)Substantially Equivalent (Special)	Sep 15, 2022