PMA supplement
P950037 S084: REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS
FDA PMA supplement · Normal 180 Day Track · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S084 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS |
| Generic name | Pulse Generator, External Pacemaker, Dual Chamber |
| Applicant | Biotronik, Inc. |
| Product code | OVJ |
| Received date | Jul 14, 2010 |
| Decision date | May 8, 2012 |
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: