PMA supplement
P900066 S003: PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
FDA PMA supplement · Normal 180 Day Track · Airgas Therapeutics, LLC
Key facts
| Original PMA | P900066 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY |
| Generic name | Gases used within eye to place pressure on detached retina |
| Applicant | Airgas Therapeutics, LLC |
| Product code | LPO |
| Received date | Sep 21, 1999 |
| Decision date | Mar 16, 2000 |
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: