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 | S003 |
Date Received | 10/12/2001 |
Decision Date | 11/09/2001 |
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 STERILIZATION PROCESS BY ELIMINATING THE POST STERILIZATION VISUAL INSPECTION FOR THE OXYFIRST FETAL SENSOR FS14-SERIES. ALSO, A CHANGE IN THE SITE OF FINAL PRODUCT DISTRIBUTION FROM THE PRESENT FACILITY IN CARLSBAD, CALIFORNIA TO A TYCO DISTRIBUTION FACILITY IN ATLANTA, GEORGIA. |
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