PMA supplement
P910077 S139: MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
FDA PMA supplement · Normal 180 Day Track · Boston Scientific
Key facts
| Original PMA | P910077 |
|---|---|
| Supplement number | S139 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) |
| Generic name | Pacemaker/icd/crt non-implanted components |
| Applicant | Boston Scientific |
| Product code | OSR |
| Received date | Sep 30, 2013 |
| Decision date | Apr 11, 2014 |
At a glance
- No Expedited review granted
- Yes 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: