CardioMEMSTM HF System
FDA premarket approval P100045/S067 · decided 2023-07-19
Approval details
- PMA number
- P100045
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CardioMEMSTM HF System
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-06-22
- Decision date
- 2023-07-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Implement new alternate laser equipment for the manufacturing of the CardioMEMS PA Sensor.
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510(k) clearances by this applicant
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|---|---|---|
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |