Medtech approvals: FDA releases May 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 51
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 26
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 547
Total Active: 379
Total On Hold: 168
Summary of All PMA Submissions
Originals: 1
Supplements: 62
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 109.5
FDA Time: 86.4 Days
MFR Time: 23.1 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P130022
5/8/15
Nevro Senza Spinal Cord Stimulation (SCS) System
Nevro Corporation
Menlo Park, CA 94025
Approval for the Nevro Senza SCS System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain.
P140002
5/22/15
Misago Peripheral Self-Expanding Stent System
Terumo Medical Corporation
Elkton, MD
21921
Approval for the Misago Peripheral Self-expanding Stent System. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or oc...
Source: Mass Device - Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
More News: Acetaminophen | Allergy | Angiography | Angioplasty | Astigmatism | Back Pain | Bipolar | Brain | Brain Cancers | Breast Augmentation | Breast Needle Aspiration | Cancer | Cancer & Oncology | Cardiology | Cardiovascular | Cardiovascular & Thoracic Surgery | Carotid Angioplasty | Carotid Endarterectomy | Chronic Pain | Colorectal Cancer | Costa Rica Health | Deep Brain Stimulation | Diabetes | Endocrinology | Erbitux | Eye Laser Surgery | Gastric (Stomach) Cancer | Gastroenterology | Gastroschisis Repair | Genetics | Health | Heart | HER2 | HIV AIDS | Intermittent Claudication | Laser Surgery | Lortab | Low Back Pain | Lumbar Spinal Stenosis | Mania | Medical Devices | Men | Microbiology | Middle East Health | Myopia (short sighted) | Neurology | Neuroscience | Neurosurgery | Operative Vaginal Delivery | Orthopaedics | Osteoarthritis | Pain | Pain Management | Pediatrics | Penile Cancer | Plastic Surgery | Radiography | Spondylolisthesis | Study | Ultrasound | Warnings