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.
Approval for modifications to the stan fetal heart rate classification and the stan simplified clinical guidelines. The device, as modified, will be marketed under the trade name stan s31 fetal heart monitor and is indicated as an adjunct to fetal heart rate monitoring to determine whether obstetrical intervention is warranted when there is increased risk of developing metabolic acidosis. The device is intended for use in patients with: 1) planned vaginal delivery; 2) >36 completed weeks gestation; 3) singleton fetus; 4) vertex presentation; and 5) ruptured amniotic membranes.
| Device | NEOVENTA'S STAN S31 FETAL HEART MONITOR |
| Generic Name | Analyzer, Data, Obstetric |
| Applicant | NEOVENTA MEDICAL AB |
| Date Received | 2007-10-11 |
| Decision Date | 2008-04-11 |
| PMA | P020001 |
| Supplement | S004 |
| Product Code | HEO |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEOVENTA MEDICAL AB norra Agatan 32 se-431 35 molndal |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020001 | Original Filing | |
| S009 | 2011-09-21 | Real-time Process |
| S008 | 2011-07-07 | 30-day Notice |
| S007 | 2009-07-23 | Normal 180 Day Track |
| S006 | 2009-09-11 | Real-time Process |
| S005 | 2008-02-04 | Real-time Process |
| S004 | 2007-10-11 | Normal 180 Day Track |
| S003 | ||
| S002 | 2007-08-13 | Real-time Process |
| S001 | 2007-06-04 | 30-day Notice |