PMA supplement
P010031 S536: Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Protecta CRT-D D334 TRM, Protecta CRT-D D334TRG; Protec
FDA PMA supplement · 30-Day Notice · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P010031 |
|---|---|
| Supplement number | S536 |
| 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; Protecta CRT-D D334 TRM, Protecta CRT-D D334TRG; Protec |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | NIK |
| Received date | Feb 25, 2016 |
| Decision date | Mar 23, 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: