CardioMEMS HF System
FDA premarket approval P100045/S065 · decided 2023-04-28
Approval details
- PMA number
- P100045
- Supplement
- S065
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CardioMEMS HF System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-03-31
- Decision date
- 2023-04-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for labeling changes being made to the users manual or system guides with updated electromagnetic compatibility (EMC) information.
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