PMA Final Decisions for August 2011by
Changes to the blister sealing operation and the inspection specifications for that operation... 55432
Changes to the blister sealing operation and the inspection specifications...
PMA Final Decisions for October 2011by
C.R. Bard, Inc.
Introduction of an automated labeling inspectionsystem... inspectionsystem and introduction of a new barcode scan system.
PMA Final Decisions for March 2011by
Medtronic® InterStim® Therapy System
Medtronic...® InterStim® Therapy System. The device is indicated for the treatment of chronic fecal incontinence...
PMA Final Decisions for August 2010by
™ Anti-HBc IgM is intended for
manual use and with the Bio-Rad EVOLIS™ Automated Microplate System..., Inc.
Mounds View, MN
Implementation of an electronic system for incoming inspection data...
PMA Final Decisions for July 2011by
Change from a manual proof-reading process to an automated proof-reading system... Systems. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing...
PMA Final Decisions for June 2010by
Boston Scientific Corporation
Maple Grove, MN
Approval for a change from a manual... Grove, MN
Change to the post-swaged inspection method from a manual to an automated process...
PMA Final Decisions for June 2011by
of a new Optical OGP SmartScope System to an existing component inspection.
P900061/S103... Vision Automated InspectionSystem (AIS) to Version 4.4.
PMA Final Decisions for April 2010by
Modification of a parameter in a receiving inspection test for silicone... Medical Systems
Modification of a parameter in a receiving inspection test...
PMA Final Decisions for May 2010by
) into a single manual, the Physician System Clinical manual.
Change from a manual in-process inspection to an automated in-process inspection.
PMA Final Decisions for September 2010by
Approval for a manual specimen preparation option to the currently... Pure System Viral Nucleic Acid
Kit for manual specimen preparation and the COBAS05® TaqMan® 48...