CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
FDA premarket approval P100045/S013 · decided 2016-11-30
Approval details
- PMA number
- P100045
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-10-31
- Decision date
- 2016-11-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Revisions to the cleanroom specification for the CardioMEMS HF System at St. Jude Medicals (SJM) Atlanta site.
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