PMA supplement
P880013 S007: HIGH FREQUENCY VENTILATOR
FDA PMA supplement · Normal 180 Day Track · Nellcor Puritan Bennett, Inc.
Key facts
| Original PMA | P880013 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HIGH FREQUENCY VENTILATOR |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | Nellcor Puritan Bennett, Inc. |
| Product code | LSZ |
| Received date | Oct 11, 1996 |
| Decision date | Jun 24, 1997 |
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: