BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
FDA premarket approval P010031/S511 · decided 2015-10-29
Approval details
- PMA number
- P010031
- Supplement
- S511
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
- Generic name
- Programmer, pacemaker
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-09-04
- Decision date
- 2015-10-29
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THREE NEW ALTERNATE INTEGRATED CIRCUITS TO BE USED IN THE DEVICES.
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