PMA supplement
P010031 S531: Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224
FDA PMA supplement · 30-Day Notice · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P010031 |
|---|---|
| Supplement number | S531 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224 |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Received date | Feb 5, 2016 |
| Decision date | Feb 29, 2016 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: