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: COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146
• Generic Name: Stimulator, fetal, acoustic
• Applicant: Ge Medical Systems, Inc.; 4502 Woodland Corporate Blvd.; Tampa, FL 33614
• PMA Number: P870025
• Supplement Number: S011
• Date Received: 09/10/2012
• Decision Date: 10/10/2012
• Withdrawal Date: 05/30/2014
• Product Code: MCP
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No