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. |
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Device | COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 |
Generic Name | Stimulator, fetal, acoustic |
Applicant | GE MEDICAL SYSTEMS, INC. 4502 WOODLAND CORPORATE BLVD TAMP, FL 33614 |
PMA Number | P870025 |
Supplement Number | S011 |
Date Received | 09/10/2012 |
Decision Date | 10/10/2012 |
Withdrawal Date
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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 |
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