The PMA application is based on data from the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15 ...

In November 2024, Perimeter reported positive topline results from the pivotal study designed to support the Company's FDA PMA for B-Series OCT with ImgAssist AI 2.0 for use during breast ...

Anika to file cosmetic tissue augmentation product PMA By Carolyn Pritchard Published: May 17, 2005 at 6:27 p.m. ET Share ...

By Reuters May 18, 201712:46 AM UTCUpdated ago May 18 (Reuters) - Avita Medical Ltd * Company on-track to file a PMA with U.S. Food & Drug Administration in mid-2017 * Co-primary endpoints ...

Contacts Contact for journalists: Siemens Healthcare Jeff Bell, +1 610-448-1477 jeffrey.t.bell@siemens.com ...

A modular PMA takes the FDA 90 days to complete its review of each module. Thus the modular approach will allow the FDA to make a decision in half the time once all information to support the basis of ...