OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
FDA premarket approval P990053/S008 · decided 2002-11-25
Approval details
- PMA number
- P990053
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- Generic name
- Oximeter, fetal pulse
- Applicant
- Covidien, LLC
- Date received
- 2002-04-16
- Decision date
- 2002-11-25
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Boulder, CO
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA. FACTORY SERVICE OPERATIONS FOR THE N-400 FETAL OXYGEN SATURATION MONITORS WILL BE PERFORMED AT THIS FACILITY.
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