FDA releases June 2013 PMA approvals

September 9, 2013 by Arezu Sarvestani

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in June 2013.


6/6/13 Wallstent® Endoprosthesis TIPS Boston Scientific Corporation
Maple Grove, MN 55311 Vendor location change. P930031/S044
6/26/13 Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System Boston Scientific Corporation
One Scimed Place 
Maple Grove, MN 55311 Change to the braiding inspection process. P930039/S090
6/19/13 CapSureFix Novus Lead, Vitatron Crystalline Lead Medtronic Inc.
Mounds View MN, 55112 Alternate suppliers for the manufacture of multiple silicone components. P940015/S027
6/28/13 Synvisc® and Synvisc-One® Synvisc® and Synvisc-One® Genzyme Corporation 
Cambridge, MA 02142 Increase in extract production. P940019/S037
6/6/13 Wallstent® Endoprosthesis Iliac Boston Scientific Corporation 
Maple Grove, MN 55311 Requested a vendor location change. P940019/S038
6/26/13 Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System Boston Scientific Corporation
One Scimed Place 
Maple Grove, MN 55311 Change to the braiding inspection process. P960011/S023
6/4/13 BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) Ferring Pharmaceuticals Incorporated 
Parsippany, NJ 07054 Add a new syringe denester machine and an alternative assembly and labeling machine. P960028/S037
6/18/13 ReZoom Multifocal IOL Abbott Medical Optics, Inc.
Santa Ana, CA 92705 New test method validation for the Ultra High Performance Liquid Chromatography (UHPLC) System. P960040/S294
6/6/13 CONFIENT, LIVIAN, INCEPTA, ENERGEN, PUNCTUA,
TELIGEN, VITALITY Families of ICDs Boston Scientific Corporation
St. Paul, MN 

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