PMA P990053S003

Device: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S003
Product code: MMA
Decision date: 2001-11-09
Classification: Oximeter, Fetal Pulse
Generic name: Oximeter, fetal pulse
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.

Current openFDA PMA Record#

Device: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Applicant: Covidien, LLC
PMA number: P990053
Supplement: S003
Product code: MMA
Generic name: Oximeter, fetal pulse
Decision date: 2001-11-09
Decision code: OK30
Date received: 2001-10-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.