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 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY |
Generic Name | Oximeter, fetal pulse |
Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8880 GORMAN ROAD LAUREL, MD 20723 |
PMA Number | P000016 |
Supplement Number | S001 |
Date Received | 05/21/2001 |
Decision Date | 11/09/2001 |
Withdrawal Date
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09/12/2007 |
Product Code |
MMA |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT WIPRO GE MEDICAL SYSTEMS, BANGALORE, INDIA. |
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