PMA supplement
P880086 S083: INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A
FDA PMA supplement · Normal 180 Day Track · ABBOTT MEDICAL
Key facts
| Original PMA | P880086 |
|---|---|
| Supplement number | S083 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | ABBOTT MEDICAL |
| Product code | DXY |
| Received date | Mar 8, 2001 |
| Decision date | Jul 11, 2001 |
| Docket number | 01M-0462 |
| Notice date | Oct 11, 2001 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: