OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
FDA premarket approval P990053/S006 · decided 2003-01-07
Approval details
- PMA number
- P990053
- Supplement
- S006
- 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
- 2002-03-26
- Decision date
- 2003-01-07
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Boulder, CO
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE N-400 FETAL PULSE OXIMETER. THE MANUFACTURING SITE IS LOCATED AT NELLCOR PURITAN BENNETT IRELAND, GALWAY, IRELAND.
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