CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
FDA premarket approval P100045/S002 · decided 2015-07-10
Approval details
- PMA number
- P100045
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-11-26
- Decision date
- 2015-07-10
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- APPROVAL FOR THE NEXT GENERATION OF HOME USE ELECTRONICS, THE I3 PATIENT ELECTRONICS.
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