Solo Pace, Inc. 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 Pace Fusion System (SOLOFUSE1)510(k)Jan 9, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 9, 2026
Solo Pace Control510(k)Jan 10, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 10, 2025