PMA
P060027: OVATIO CRT SYSTEM
FDA PMA · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) · MicroPort CRM S.r.l.
Key facts
| PMA number | P060027 |
|---|---|
| Trade name | OVATIO CRT SYSTEM |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | MicroPort CRM S.r.l. |
| Owner/operator | MicroPort CRM S.R.L. |
| Product code | NIK |
| Approval date | May 15, 2008 |
| Docket number | 08M-0426 |
| Notice date | Jul 28, 2008 |
| Establishment registration | 1000165971 |
| FEI number | 1000165971 |
At a glance
- 100–999 Supplements
- Nov 25, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: