CardioMEMS HF System
FDA premarket approval P100045/S077 · decided 2025-02-06
Approval details
- PMA number
- P100045
- Supplement
- S077
- Supplement type
- Normal 180 Day 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
- 2024-07-05
- Decision date
- 2025-02-06
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- approval for version C2.0 of the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal and introduction of the CardioGuide HF Application for use with the CardioMEMS HF System.
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |