PMA supplement
P950037 S160: ACROS DR/SR/SLR/D/S,AXIOS DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S
FDA PMA supplement · Real-Time Process · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S160 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ACROS DR/SR/SLR/D/S,AXIOS DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Biotronik, Inc. |
| Product code | NVZ |
| Received date | Dec 16, 2015 |
| Decision date | Apr 13, 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: