CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT
FDA premarket approval P010031/S259 · decided 2011-11-10
Approval details
- PMA number
- P010031
- Supplement
- S259
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-06-09
- Decision date
- 2011-11-10
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDITION OF A CLEANING PROCESS AT THE SUPPLIER.
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