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.
Addition of an inspection test for the device.
| Device | NEOVENTA'S STAN S31 FETAL HEART MONITOR |
| Generic Name | Analyzer, Data, Obstetric |
| Applicant | NEOVENTA MEDICAL AB |
| Date Received | 2011-07-07 |
| Decision Date | 2011-08-04 |
| PMA | P020001 |
| Supplement | S008 |
| Product Code | HEO |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |