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GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
MATRIA HEALTHCARE, INC.
Trade Name
GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
Generic Name
Monitor, uterine contraction, external (for use in clinic)
Decision Date
9/12/1990
Days to Decision
301 days
Decision Code
APRL
FDA Decision
Reclassification after approval

GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
MATRIA HEALTHCARE, INC.
Trade Name
GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
Generic Name
Monitor, uterine contraction, external (for use in clinic)
Decision Date
9/12/1990
Days to Decision
301 days
Decision Code
APRL
FDA Decision
Reclassification after approval