GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
FDA premarket approval P890063/S002 · decided 1991-04-10
Approval details
- PMA number
- P890063
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
- Generic name
- Monitor, uterine contraction, external (for use in clinic)
- Applicant
- Matria Healthcare, Inc.
- Date received
- 1990-12-21
- Decision date
- 1991-04-10
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- HFM
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Marietta, GA
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