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.
Changes to the suppliers for components of the fast device.
| Device | FETAL ACOUSTIC STIMULATOR |
| Generic Name | Stimulator, Fetal, Acoustic |
| Applicant | GE MEDICAL SYSTEMS, INC. |
| Date Received | 2011-09-12 |
| Decision Date | 2011-10-12 |
| PMA | P870025 |
| Supplement | S010 |
| Product Code | MCP |
| 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 | 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) |