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Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news
Predictors of Long-Term Outcomes in Patients with Significant Myxomatous Mitral Regurgitation Undergoing Exercise Echocardiography.
CONCLUSIONS: In patients with ≥III+ myxomatous MR undergoing ExEc, lower %age-gender predicted METS, lower HRR, atrial fibrillation, lower LV ejection fraction and high resting RVSP predicted worse outcomes.
PMID: 24396041 [PubMed - as supplied by publisher]
Source: Circulation - January 6, 2014 Category: Cardiology Authors: Naji P, Griffin BP, Asfahan F, Barr TS, Rodriguez LL, Grimm R, Agarwal S, Stewart WJ, Mihaljevic T, Gillinov AM, Desai MY Tags: Circulation Source Type: research