CardioMEMS patient and hospital electronics
FDA premarket approval P100045/S022 · decided 2018-03-06
Approval details
- PMA number
- P100045
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CardioMEMS patient and hospital electronics
- Generic name
- System, hemodynamic, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-07-12
- Decision date
- 2018-03-06
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- Approval for an alternate manufacturing site located at St. Jude Medical LLC, SJM Technology Center, One St. Jude Medical Drive, Saint Paul, Minnesota.
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