PMA P100045S089
- Device
- CardioMEMS™ HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S089
- Product code
- MOM
- Decision date
- 2026-05-13
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- implementation of alternate pouch sealer equipment
Current openFDA PMA Record#
- Device
- CardioMEMS™ HF System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100045
- Supplement
- S089
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2026-05-13
- Decision code
- OK30
- Date received
- 2026-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of alternate pouch sealer equipment