PMA supplement
P890063 S002: GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
FDA PMA supplement · Normal 180 Day Track · Matria Healthcare, Inc.
Key facts
| Original PMA | P890063 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | 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. |
| Product code | HFM |
| Received date | Dec 21, 1990 |
| Decision date | Apr 10, 1991 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: