PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D
FDA premarket approval P010031/S344 · decided 2013-09-25
Approval details
- PMA number
- P010031
- Supplement
- S344
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-12-19
- Decision date
- 2013-09-25
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDING NON-MEDTRONIC DEFIBRILLATION LEADS TO RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) LABELING.
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