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.
Approval for a manufacturing facility located at wipro ge medical systems, bangalore, india.
Device | COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR |
Generic Name | Stimulator, Fetal, Acoustic |
Applicant | GE MEDICAL SYSTEMS, INC. |
Date Received | 2001-05-21 |
Decision Date | 2001-11-09 |
PMA | P870025 |
Supplement | S006 |
Product Code | MCP |
Advisory Committee | Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location 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) |