OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
FDA premarket approval P990053/S010 · decided 2002-11-15
Approval details
- PMA number
- P990053
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Generic name
- Oximeter, fetal pulse
- Applicant
- Covidien, LLC
- Date received
- 2002-10-17
- Decision date
- 2002-11-15
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Boulder, CO
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING.
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