PMA supplement
P030054 S295: PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET
FDA PMA supplement · 135 Review Track For 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P030054 |
|---|---|
| Supplement number | S295 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | ABBOTT MEDICAL |
| Product code | NIK |
| Received date | Oct 26, 2015 |
| Decision date | Apr 28, 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: