This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | 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 | 1991-06-11 |
| Decision Date | 1994-01-31 |
| PMA | P890063 |
| Supplement | S003 |
| Product Code | HFM |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MATRIA HEALTHCARE, INC. 1850 Parkway Place suite 1200 marietta, GA 30067 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890063 | Original Filing | |
| S004 | 1993-04-07 | Normal 180 Day Track |
| S003 | 1991-06-11 | Normal 180 Day Track |
| S002 | 1990-12-21 | Normal 180 Day Track |
| S001 |