PMA P890063S002
- Device
- GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
- Applicant
- Matria Healthcare, Inc.
- PMA number
- P890063
- Supplement
- S002
- Product code
- HFM
- Decision date
- 1991-04-10
- Generic name
- Monitor, uterine contraction, external (for use in clinic)
Current openFDA PMA Record#
- Device
- GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
- Applicant
- Matria Healthcare, Inc.
- PMA number
- P890063
- Supplement
- S002
- Product code
- HFM
- Generic name
- Monitor, uterine contraction, external (for use in clinic)
- Decision date
- 1991-04-10
- Decision code
- APPR
- Date received
- 1990-12-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename