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 | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
Generic Name | Oximeter, fetal pulse |
Applicant | Covidien, LLC 6135 Gunbarrel Avenue Boulder, CO 80301 |
PMA Number | P990053 |
Supplement Number | S007 |
Date Received | 04/05/2002 |
Decision Date | 04/18/2002 |
Withdrawal Date
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06/02/2017 |
Product Code |
MMA |
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 CHANGE IN THE MANUFACTURING SITE FOR THE FETAL SENSOR EMITTER, A COMPONENT OF THE OXIFIRST FETAL SENSOR. THE SENSOR EMITTER WILL BE MANUFACTURED AT THE TYCO FACILITY IN INSURGENTES, TIJUANA, MEXICO, WHERE THE FETAL SENSORS ARE MANUFACTURED. |
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