PMA supplement
P960043 S118: Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System
FDA PMA supplement · Panel Track · Abbott Vascular, Inc.
Key facts
| Original PMA | P960043 |
|---|---|
| Supplement number | S118 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System |
| Generic name | Device, hemostasis, vascular |
| Applicant | Abbott Vascular, Inc. |
| Product code | MGB |
| Received date | Sep 19, 2022 |
| Decision date | Jun 2, 2023 |
| Docket number | 23M-2708 |
| Notice date | Jul 7, 2023 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: