PMA
P010015: MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Medtronic, Inc.
Key facts
| PMA number | P010015 |
|---|---|
| Trade name | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LWP |
| Approval date | Aug 28, 2001 |
| Docket number | 01M-0373 |
| Notice date | Aug 30, 2001 |
| 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- No Withdrawn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: