PMA supplement
P840068 S012: MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD
FDA PMA supplement · Normal 180 Day Track · Boston Scientific
Key facts
| Original PMA | P840068 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific |
| Product code | LWP |
| Received date | Feb 15, 1990 |
| Decision date | May 17, 1991 |
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: