Note: 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 |
Generic Name | Stimulator, fetal, acoustic |
Applicant | GE MEDICAL SYSTEMS, INC. 4502 WOODLAND CORPORATE BLVD TAMP, FL 33614 |
PMA Number | P870025 |
Supplement Number | S004 |
Date Received | 11/09/1995 |
Decision Date | 02/01/1996 |
Withdrawal Date
|
05/30/2014 |
Product Code |
MCP |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE QUALITY CONTROL AND MANUFACUTRING PRACTICES FOR THE TRANSDUCER IN COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR |
|
|