PMA
P160025: ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Biotronik AG
Key facts
| PMA number | P160025 |
|---|---|
| Trade name | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | Biotronik AG |
| Owner/operator | BIOTRONIK, INC. |
| Product code | NIP |
| Approval date | Mar 23, 2017 |
| Docket number | 17M-1845 |
| Notice date | Mar 29, 2017 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 10–99 Supplements
- Sep 11, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: