BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D;
FDA premarket approval P010031/S415 · decided 2014-01-16
Approval details
- PMA number
- P010031
- Supplement
- S415
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D;
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-12-19
- Decision date
- 2014-01-16
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
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