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Specialty: Medical Devices
Condition: Back Pain
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Total 2 results found since Jan 2013.
Hemostasis Solution Controls Bleeding during Surgery
A novel handheld device delivers a powder based on collagen to help surgeons achieve hemostatic bleeding control during surgical procedures.The Biom ’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for...
Source: Medical Hemostat - January 2, 2018 Category: Medical Devices Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 80
Summary of PMA Originals Under Review
Total Under Review: 53
Total Active: 22
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 575
Total Active: 418
Total On Hold: 157
Summary of All PMA Submissions
Originals: 4
Supplements: 72
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 80
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 115.2
FDA Time: 97.1 ...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
