PMA
P970013: MICRONY PACEMAKERS
FDA PMA · Pulse-generator, single chamber, sensor driven, implantable · ABBOTT MEDICAL
Key facts
| PMA number | P970013 |
|---|---|
| Trade name | MICRONY PACEMAKERS |
| Generic name | Pulse-generator, single chamber, sensor driven, implantable |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWO |
| Approval date | Dec 21, 2000 |
| Docket number | 01M-0013 |
| Notice date | Jan 16, 2001 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Jul 21, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: