PMA P870025S011
- Device
- COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S011
- Product code
- MCP
- Decision date
- 2012-10-10
- Generic name
- Stimulator, fetal, acoustic
Current openFDA PMA Record#
- Device
- COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S011
- Product code
- MCP
- Generic name
- Stimulator, fetal, acoustic
- Decision date
- 2012-10-10
- Decision code
- APPR
- Date received
- 2012-09-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename