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.
| Device | COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 |
| Generic Name | Stimulator, Fetal, Acoustic |
| Applicant | GE MEDICAL SYSTEMS, INC. |
| Date Received | 2012-09-10 |
| Decision Date | 2012-10-10 |
| PMA | P870025 |
| Supplement | S011 |
| Product Code | MCP |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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) |