PMA supplement
P050023 S122: S 75-G OTW; S 75-K OTW; S 85-G OTW; S 85-K OTW
FDA PMA supplement · 30-Day Notice · Biotronik, Inc.
Key facts
| Original PMA | P050023 |
|---|---|
| Supplement number | S122 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | S 75-G OTW; S 75-K OTW; S 85-G OTW; S 85-K OTW |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | Biotronik, Inc. |
| Product code | MRM |
| Received date | Jul 10, 2018 |
| Decision date | Aug 9, 2018 |
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: