PMA
P010031: CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION
FDA PMA · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) · Medtronic Cardiac Rhythm Disease Management
Key facts
| PMA number | P010031 |
|---|---|
| Trade name | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Owner/operator | Medtronic, Inc. |
| Product code | NIK |
| Approval date | Jun 26, 2002 |
| Docket number | 02M-0381 |
| Notice date | Aug 26, 2002 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Oct 5, 2026 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- No Withdrawn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: