PMA supplement
P870038 S005: STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120
FDA PMA supplement · Real-Time Process · Edwards Lifesciences, LLC
Key facts
| Original PMA | P870038 |
|---|---|
| Supplement number | S005 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120 |
| Generic name | HEART-VALVE, MECHANICAL |
| Applicant | Edwards Lifesciences, LLC |
| Product code | LWQ |
| Received date | Feb 11, 2005 |
| Decision date | Jul 20, 2005 |
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: