CARDIOMEMS HF SYSTEM
FDA premarket approval P100045/S015 · decided 2017-08-03
Approval details
- PMA number
- P100045
- Supplement
- S015
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARDIOMEMS HF SYSTEM
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-11-18
- Decision date
- 2017-08-03
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for removal of a chemical processing agent from production of their coating used on the delivery system tether wire of the CardioMEMS HF System.
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