Stryker Will Discuss Rejected OP-1 PMA At Upcoming Meeting With FDA
This article was originally published in The Gray Sheet
Executive Summary
Stryker expects to meet with FDA by March 1 to discuss the agency's "not approvable" letter for OP-1 bone growth factor for treating nonunion fractures.
You may also be interested in...
Off-Label Concerns With InFuse Raised, But Panel Decides Against Bundling
Medtronic/Sofamor Danek successfully avoided a proposed condition that would have bundled its LT-Cage lumbar tapered fusion device with its InFuse bone graft during FDA's Orthopedic & Rehabilitation Devices Panel review Jan. 10
Off-Label Concerns With InFuse Raised, But Panel Decides Against Bundling
Medtronic/Sofamor Danek successfully avoided a proposed condition that would have bundled its LT-Cage lumbar tapered fusion device with its InFuse bone graft during FDA's Orthopedic & Rehabilitation Devices Panel review Jan. 10
Stryker OP-1 Gains HDE Status For Failed Long-Bone Nonunion Fractures
Stryker plans to begin making its OP-1 (Osteogenic Protein 1) bone morphogenetic protein implant available in the U.S. by year-end under a humanitarian device exemption received from FDA Oct. 17, becoming the first company to have a BMP product reach the U.S. market.