CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTO
FDA premarket approval P010031/S203 · decided 2010-07-16
Approval details
- PMA number
- P010031
- Supplement
- S203
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-06-18
- Decision date
- 2010-07-16
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES IN PLATINUM FLOW ON COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) AT THE SUPPLIER LOCATION.
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