Requests that the FDA require Postmarket Surveillance, Mandate IDE and PMA Applications, Investigate Potential Misbranding, and Order a Labeling Change to Restrict enVast (K253407) to Guideline-Directed Selective/Bailout Use Only in STEMI with Persistent Large Thrombus Burden | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-3102

Requests that the FDA require Postmarket Surveillance, Mandate IDE and PMA Applications, Investigate Potential Misbranding, and Order a Labeling Change to Restrict enVast (K253407) to Guideline-Directed Selective/Bailout Use Only in STEMI with Persistent Large Thrombus Burden

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 25, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS)	Mar 25, 2026	--

Keywords

CDRH

Citizen Petition

Harmed Americans for Reform

in Medical-Device Safety Corp. (HARMS)

Requests that the FDA require

Postmarket Surveillance, Mandate IDE and

PMA Applications, Investigate Potential

Misbranding, and Order a Labeling Change to

Data from Regulations.gov