Premarket Approval (PMA)

Note: 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.

• Device: FETAL ACOUSTIC STIMULATOR
• Generic Name: Stimulator, fetal, acoustic
• Applicant: GE MEDICAL SYSTEMS, INC.; 4502 WOODLAND CORPORATE BLVD; TAMP, FL 33614
• PMA Number: P870025
• Supplement Number: S010
• Date Received: 09/12/2011
• Decision Date: 10/12/2011
• Withdrawal Date: 05/30/2014
• Product Code: MCP
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGES TO THE SUPPLIERS FOR COMPONENTS OF THE FAST DEVICE.