CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D
FDA premarket approval P010031/S315 · decided 2013-01-03
Approval details
- PMA number
- P010031
- Supplement
- S315
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-06-19
- Decision date
- 2013-01-03
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO UPDATE THE DEVICE LABELING WITH THE RESULTS FROM THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) POST-APPROVAL STUDY (PAS).
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