PMA P100045S045
- Device
- CardioMEMS HS System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S045
- Product code
- MOM
- Decision date
- 2020-08-14
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Manufacturing process changes to the wafer bonding of the PA Pressure Sensor.
Current openFDA PMA Record#
- Device
- CardioMEMS HS System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S045
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2020-08-14
- Decision code
- OK30
- Date received
- 2020-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process changes to the wafer bonding of the PA Pressure Sensor.