pma
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Spine
FDA Accepts & Closes Empirical Spine’s LimiFlex™ PMA Module II As A Motion-Preserving Alternative To Lumbar Fusion
SAN CARLOS, Calif., July 13, 2022 /PRNewswire/ — Empirical Spine, Inc., a medical device company creating a new class of spinal implant…
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Spine
Centinel Spine® Receives FDA Approval for 3 Additional prodisc® Cervical Total Disc Replacement Devices
Centinel Spine now has four PMA approved cervical Total Disc Replacement (TDR) devices, offering the broadest spectrum of solutions to…
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Regulatory
FDA Grants PMA for the AccelStim Bone Growth Stimulation Device — Expanding Orthofix’s Portfolio of Market-Leading Bone Healing Therapy Solutions
May 4, 2022 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus,…
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Regulatory
FDA approves CartiHeal’s Implant for the Treatment of Cartilage and Osteochondral Defects
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of…
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Spine
AxioMed LLC Files PMA Module II of III targeting 2022 FDA Approval of The First and Only Viscoelastic Lumbar Disc Replacement to Complete an IDE Clinical Study
AxioMed takes another historic step towards achieving FDA approval of its lumbar viscoelastic total disc replacement after submitting PMA Module…
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Regulatory
AxioMed LLC Reports Landmark Filing of Initial PMA Module to FDA as the First Viscoelastic Lumbar Artificial Disc Replacement to Complete an IDE Clinical Study
AxioMed seeks to get FDA clearance in 2022 to press its leadership position as the only viscoelastic total disc replacement…
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Spine
Simplify Medical Completes PMA Submission for 2-Level Simplify Disc IDE Study
Builds on recent 1-Level PMA Approval SUNNYVALE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) — Simplify Medical, Inc., maker of the…
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Biologics
Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data
WESTMINSTER, Colo., Nov. 18, 2019 /PRNewswire/ — Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has…
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Hospitals
Intrinsic Therapeutics announces the Filing of PMA Application for its Barricaid® Anular Closure Device for Lumbar Discectomy Patients.
BOSTON, Dec. 21, 2016 /PRNewswire/ — Intrinsic Therapeutics, Inc. announced today that the filing of its Pre-Market Approval (PMA) application with the Food…
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Hospitals
MCRA Assists Cartiva, Inc. with Obtaining FDA PMA Approval for the Company’s Synthetic Cartilage Implant (SCI)
WASHINGTON, July 20, 2016 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application…
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Extremities
FDA Questions First PMA for Synthetic Cartilage Implant Ahead of Advisory Panel
Posted 18 April 2016 By Zachary Brennan The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health…
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Hospitals
Cerapedics Receives FDA Approval for i-FACTOR™ Peptide Enhanced Bone Graft in Cervical Spine Surgery
WESTMINSTER, Colo., Nov. 3, 2015 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, announced today the U.S. Food and Drug Administration (FDA) has approved…
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Hospitals
New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications
By Stewart Eisenhart In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the…
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MCRA Assists VertiFlex, Inc. with Obtaining FDA PMA Approval for the Superion® Interspinous Spacer System
WASHINGTON, June 24, 2015 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application…
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Hospitals
Regulatory affairs for medical device startups
February 13, 2015 by Andrew Ahn Instilling a robust quality management system as soon as possible is crucial in becoming a successful…
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