PMA
P190027: Tack Endovascular System (4F, 1.5-4.5mm)
FDA PMA · Scaffold, dissection repair · Philips Image Guided Therapy Corporation (Formerly Intact)
Key facts
| PMA number | P190027 |
|---|---|
| Trade name | Tack Endovascular System (4F, 1.5-4.5mm) |
| Generic name | Scaffold, dissection repair |
| Applicant | Philips Image Guided Therapy Corporation (Formerly Intact) |
| Owner/operator | Philips Medical Systems International BV |
| Product code | QCT |
| Approval date | Apr 10, 2020 |
| Docket number | 20M-1286 |
| Notice date | Apr 14, 2020 |
| Establishment registration | 3016257349 |
| FEI number | 3016257349 |
At a glance
- 1–9 Supplements
- Nov 9, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: