FETAL ACOUSTIC STIMULATOR

FDA Premarket Approval P870025 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Changes to the suppliers for components of the fast device.

DeviceFETAL ACOUSTIC STIMULATOR
Generic NameStimulator, Fetal, Acoustic
ApplicantGE MEDICAL SYSTEMS, INC.
Date Received2011-09-12
Decision Date2011-10-12
PMAP870025
SupplementS010
Product CodeMCP 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GE MEDICAL SYSTEMS, INC. 4502 Woodland Corporate Blvd tamp, FL 33614

Supplemental Filings

Supplement NumberDateSupplement Type
P870025Original Filing
S011 2012-09-10 Special (immediate Track)
S010 2011-09-12 30-day Notice
S009 2009-08-05 135 Review Track For 30-day Notice
S008 2005-08-01 135 Review Track For 30-day Notice
S007 2005-03-03 30-day Notice
S006 2001-05-21 Normal 180 Day Track
S005 1996-02-08 Normal 180 Day Track
S004 1995-11-09 Normal 180 Day Track
S003 1995-01-27 Normal 180 Day Track
S002 1994-01-03 Normal 180 Day Track
S001 1988-10-11 Special (immediate Track)

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