This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY |
| Generic Name | Stimulator, Fetal, Acoustic |
| Applicant | GE MEDICAL SYSTEMS, INC. |
| Date Received | 1987-05-20 |
| Decision Date | 1988-08-31 |
| Notice Date | 1988-11-30 |
| PMA | P870025 |
| Supplement | S |
| Product Code | MCP |
| Docket Number | 88M-0346 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GE MEDICAL SYSTEMS, INC. 4502 Woodland Corporate Blvd tamp, FL 33614 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870025 | Original Filing | |
| S011 | 2012-09-10 | Special (immediate Track) |
| S010 | 2011-09-12 | 30-day Notice |
| S009 | 2009-08-05 | 135 Review Track For 30-day Notice |
| S008 | 2005-08-01 | 135 Review Track For 30-day Notice |
| S007 | 2005-03-03 | 30-day Notice |
| S006 | 2001-05-21 | Normal 180 Day Track |
| S005 | 1996-02-08 | Normal 180 Day Track |
| S004 | 1995-11-09 | Normal 180 Day Track |
| S003 | 1995-01-27 | Normal 180 Day Track |
| S002 | 1994-01-03 | Normal 180 Day Track |
| S001 | 1988-10-11 | Special (immediate Track) |