Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015:
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 69
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Summary of PMA Supplements Under Review
Total Under Review: 583
Total Active: 433
Total On Hold: 150
Summary of All PMA Submissions
Originals: 4
Supplements: 75
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 193.4
FDA Time: 103.0 Days
MFR Time: 90.4 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P130018
11/24/15
ProACT™ Adjustable Continence Therapy for Men
Uromedica, Inc.
Plymouth, MN 55441
Approval for the ProACT Adjustable Continence Therapy for Men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy.
P130028
11/20/15
Algovita Spinal Cord Stimulation System
Algostim, LLC
Blaine, MN
55449
Approval for the Algovita Spinal Cord Stimulation System. This device is indicated as an aid in the management of chr...
Source: Mass Device - Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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