PMA supplement
P980050 S082: DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR
FDA PMA supplement · Real-Time Process · Medtronic, Inc.
Key facts
| Original PMA | P980050 |
|---|---|
| Supplement number | S082 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic, Inc. |
| Product code | LWS |
| Received date | Apr 18, 2013 |
| Decision date | Jun 11, 2013 |
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: