PMA supplement
P070008 S064: CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP,
FDA PMA supplement · 135 Review Track For 30-Day Notice · Biotronik, Inc.
Key facts
| Original PMA | P070008 |
|---|---|
| Supplement number | S064 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP, |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Biotronik, Inc. |
| Product code | NKE |
| Received date | Apr 29, 2015 |
| Decision date | Jan 28, 2016 |
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: