PMA supplement
P070008 S059: CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP
FDA PMA supplement · 30-Day Notice · Biotronik, Inc.
Key facts
| Original PMA | P070008 |
|---|---|
| Supplement number | S059 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Biotronik, Inc. |
| Product code | NKE |
| Received date | Feb 4, 2015 |
| Decision date | Feb 20, 2015 |
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: