OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
FDA premarket approval P990053/S007 · decided 2002-04-18
Approval details
- PMA number
- P990053
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Generic name
- Oximeter, fetal pulse
- Applicant
- Covidien, LLC
- Date received
- 2002-04-05
- Decision date
- 2002-04-18
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Boulder, CO
- 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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