CardioMEMS HF System
FDA premarket approval P100045/S068 · decided 2023-07-26
Approval details
- PMA number
- P100045
- Supplement
- S068
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- CardioMEMS HF System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-06-22
- Decision date
- 2023-07-26
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval of the revised protocol as well as Statistical Analysis Plan for the post-approval study (PAS) protocol.
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