PMA supplement
P950037 S116: VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.
FDA PMA supplement · Normal 180 Day Track · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S116 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC. |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Biotronik, Inc. |
| Product code | NVZ |
| Received date | Dec 18, 2012 |
| Decision date | Mar 18, 2013 |
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: