PMA P870025S009
- Device
- FETAL ACOUSTIC STIMULATOR (FAST)
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S009
- Product code
- MCP
- Decision date
- 2010-04-23
- Generic name
- Stimulator, fetal, acoustic
- Approval order statement
- APPROVAL FOR A CHANGE IN SUPPLIER OF A COIL ASSEMBLY.
Current openFDA PMA Record#
- Device
- FETAL ACOUSTIC STIMULATOR (FAST)
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S009
- Product code
- MCP
- Generic name
- Stimulator, fetal, acoustic
- Decision date
- 2010-04-23
- Decision code
- APPR
- Date received
- 2009-08-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN SUPPLIER OF A COIL ASSEMBLY.