PMA P100045S037
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S037
- Product code
- MOM
- Decision date
- 2019-03-07
- Classification
- System, Hemodynamic, Implantable
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- New heat sealer for sealing device pouches.
Current openFDA PMA Record#
- Device
- CardioMEMS HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S037
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2019-03-07
- Decision code
- OK30
- Date received
- 2019-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New heat sealer for sealing device pouches.