CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO
FDA premarket approval P010031/S216 · decided 2010-10-15
Approval details
- PMA number
- P010031
- Supplement
- S216
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-09-16
- Decision date
- 2010-10-15
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS.
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