CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
FDA premarket approval P100045/S008 · decided 2016-05-02
Approval details
- PMA number
- P100045
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-03-15
- Decision date
- 2016-05-02
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for an alternate contract sterilizer site located at St Jude Medical-Sylmar, 15900 Valley View Court, Sylmar, California, 93342, to perform as an alternate ethylene oxide sterilization vendor for the CardioMEMS PA Sensor and Delivery Catheter.
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