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.
Redesign of the wiring arrangement within the transducer component of the system.
| Device | STAN S31 FETAL HEART MONITOR |
| Generic Name | Analyzer, Data, Obstetric |
| Applicant | NEOVENTA MEDICAL AB |
| Date Received | 2007-06-04 |
| Decision Date | 2007-07-03 |
| PMA | P020001 |
| Supplement | S001 |
| 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 |