CARDIOMEMS HF SYSTEM
FDA premarket approval P100045/S007 · decided 2019-01-04
Approval details
- PMA number
- P100045
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARDIOMEMS HF SYSTEM
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-09-04
- Decision date
- 2019-01-04
- Days to decision
- 1218 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for increasing the shelf life of the system.
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