PMA P100045S048
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S048
- Product code
- MOM
- Decision date
- 2021-03-09
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Manufacturing parameter changes to the UV curing process.
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S048
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2021-03-09
- Decision code
- OK30
- Date received
- 2021-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing parameter changes to the UV curing process.