PMA P870025S008
- Device
- FETAL ACOUSTIC STIMULATOR
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S008
- Product code
- MCP
- Decision date
- 2006-03-02
- Generic name
- Stimulator, fetal, acoustic
- Approval order statement
- APPROVAL FOR VENDOR CHANGES FOR THE FOLLOWING COMPONENTS: DIE CAST FRAME AND PRINTED CIRCUIT BOARD (PCB) AND A CHANGE IN ADHESIVE MATERIAL.
Current openFDA PMA Record#
- Device
- FETAL ACOUSTIC STIMULATOR
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S008
- Product code
- MCP
- Generic name
- Stimulator, fetal, acoustic
- Decision date
- 2006-03-02
- Decision code
- APPR
- Date received
- 2005-08-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR VENDOR CHANGES FOR THE FOLLOWING COMPONENTS: DIE CAST FRAME AND PRINTED CIRCUIT BOARD (PCB) AND A CHANGE IN ADHESIVE MATERIAL.