CARDIOMEMS HF SYSTEM
FDA premarket approval P100045/S012 · decided 2016-11-16
Approval details
- PMA number
- P100045
- Supplement
- S012
- 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
- 2016-10-17
- Decision date
- 2016-11-16
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for changes to the Hospital System Guide for the CardioMEMS HF System to clarify the instructions for powering down the hospital electronics unit (CM3000), and more detailed instructions for the Merlin.net setup and access.
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