OXIFIRST(TM) FETAL SENSOR FS14-SERIES
FDA premarket approval P990053/S002 · decided 2001-12-19
Approval details
- PMA number
- P990053
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- OXIFIRST(TM) FETAL SENSOR FS14-SERIES
- Generic name
- Oximeter, fetal pulse
- Applicant
- Covidien, LLC
- Date received
- 2001-06-05
- Decision date
- 2001-12-19
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Boulder, CO
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT TYCO HEALTHCARE GROUP, TIJUANA, MEXICO.
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