Replacement Heart-Valve — Edwards Lifesciences, LLC (PMA P010041)
Replacement Heart-Valve — Edwards Lifesciences, LLC (PMA P010041) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Replacement Heart-Valve; Applicant: Edwards Lifesciences, LLC; Clearance track: PMA.
| Device name | Replacement Heart-Valve |
|---|---|
| Applicant | Edwards Lifesciences, LLC |
| Clearance track | PMA |
| Submission number | P010041 |
| Decision | OK30 |
| Decision date | 2012-03-22 |
| Date received | 2012-02-21 |
| Product code | DYE |
| Device class | 3 |
| Medical specialty | Cardiovascular |
| Applicant location | CA |
| Source | openFDA device |
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$1999/mo
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