PMA
P150023: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
FDA PMA · Absorbable coronary drug-eluting stent · Abbott Vascular, Inc.
Key facts
| PMA number | P150023 |
|---|---|
| Trade name | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM |
| Generic name | Absorbable coronary drug-eluting stent |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | PNY |
| Approval date | Jul 5, 2016 |
| Docket number | 16M-1914 |
| Notice date | Jul 21, 2016 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- May 30, 2018 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- No Withdrawn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: