BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
FDA premarket approval P010031/S387 · decided 2013-10-04
Approval details
- PMA number
- P010031
- Supplement
- S387
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-07-10
- Decision date
- 2013-10-04
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- NIK
- 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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