CONCERTO / PROTECTA
FDA premarket approval P010031/S293 · decided 2012-03-22
Approval details
- PMA number
- P010031
- Supplement
- S293
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO / PROTECTA
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-27
- Decision date
- 2012-03-22
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
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