CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4
FDA premarket approval P010031/S306 · decided 2012-06-04
Approval details
- PMA number
- P010031
- Supplement
- S306
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-05-11
- Decision date
- 2012-06-04
- Days to decision
- 24 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- INCORPORATE PLATING BAKE TEST AS PART OF THE MONITORING CONTROL PLAN PERFORMED AT THE SUPPLIER.
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