PMA supplement
P980049 S023: ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE FOR CHORUS MODELS 6001, 6003, 6004, 6033, AND 6034
FDA PMA supplement · Real-Time Process · MicroPort CRM S.r.l.
Key facts
| Original PMA | P980049 |
|---|---|
| Supplement number | S023 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE FOR CHORUS MODELS 6001, 6003, 6004, 6033, AND 6034 |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | MicroPort CRM S.r.l. |
| Product code | MRM |
| Received date | Jul 11, 2006 |
| Decision date | Jul 26, 2006 |
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: