Petitioner requests that the U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health (“CDRH”) withdraw approval of Premarket Approval Number P140018 for the VenaSeal® Closure System (“VenaSeal®”). | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2015-P-2854

Petitioner requests that the U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health (“CDRH”) withdraw approval of Premarket Approval Number P140018 for the VenaSeal® Closure System (“VenaSeal®”).

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensAug 12, 2015

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDRH to Olsson Frank Weeda Terman Matz PC	Apr 22, 2026	--

Comment Statistics

Total Comments

Keywords

Citizen Petition

CDRH

Premarket Approval Number P140018

VenaSeal

Venaseal Closure System

2015-5269

Provensis

BTG International Group

CLOSED

Data from Regulations.gov