GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
FDA premarket approval P890063 · decided 1990-09-12
Approval details
- PMA number
- P890063
- Trade name
- GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
- Generic name
- Monitor, uterine contraction, external (for use in clinic)
- Applicant
- Matria Healthcare, Inc.
- Date received
- 1989-11-15
- Decision date
- 1990-09-12
- Days to decision
- 301 days
- Decision code
- APRL
- Product code
- HFM
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Marietta, GA
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