Premarket Approval Application (PMA)
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Biologics
Cerapedics Files Final Module of the PMA Application for FDA Approval of a new P-15 Peptide Enhanced Bone Graft for Lumbar Spine Fusion
If approved, the breakthrough product will bring Cerapedics’ P-15 Peptide to lumbar spine fusion with a TLIF indication, making it…
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Spine
Centinel Spine® PMA Application for First-of-its-Kind 2-Level prodisc® C Vivo and prodisc C SK Match-the-Disc™ Cervical Total Disc Replacement System Filed and Proceeding with Substantive Review
The clinical trial evaluated the safety and effectiveness of the prodisc C Vivo and prodisc C SK system by comparing it with…
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Regulatory
Premia Spine TOPS™ System Achieves FDA Premarket Approval with Superiority-to-Fusion Label
Data reveals significant superiority of TOPS facet joint replacement system over TLIF fusion in treating degenerative spondylolisthesis with stenosis. NORWALK,…
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Regulatory
Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for LimiFlex™ Dynamic Sagittal Tether™
LimiFlex™ DST™ Is Designed for a New Class of Lumbar Stabilization Surgery That Meets the Demands of Value-Based Care. SAN…
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Regulatory
MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc
WASHINGTON, March 7, 2019 /PRNewswire/ — MCRA, LLC announced today its role in the successful Premarket Approval (PMA) application decision by the U.S.…
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