PMA P990053S002
- Device
- OXIFIRST(TM) FETAL SENSOR FS14-SERIES
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S002
- Product code
- MMA
- Decision date
- 2001-12-19
- Classification
- Oximeter, Fetal Pulse
- Generic name
- Oximeter, fetal pulse
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT TYCO HEALTHCARE GROUP, TIJUANA, MEXICO.
Current openFDA PMA Record#
- Device
- OXIFIRST(TM) FETAL SENSOR FS14-SERIES
- Applicant
- Covidien, LLC
- PMA number
- P990053
- Supplement
- S002
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2001-12-19
- Decision code
- APPR
- Date received
- 2001-06-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT TYCO HEALTHCARE GROUP, TIJUANA, MEXICO.