Skip to main content
. 2024 Nov 15;22:715. doi: 10.1186/s12951-024-02901-x

Table 3.

List of the NMD approved by FDA for marketing through the PMA process. Extracted from Premarket Approval (PMA) database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm (keyword: nano)

Medical application/specialty Device/trade name Applicant Decision date Withdrawal date Nanomaterial Indication
Cardiovascular Cobra PzF NanoCoated Coronary Stent System Celonova Biosciences, Inc. 02/21/2017 etc.* 12/22/2022 Polyphosphazene nanocoating Coronary stent system for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease from de novo lesions in native coronary arteries

*Disc.: Due to the complex regulatory process and need for continuous improvement, medical devices often undergo multiple revisions and approvals, resulting in several decision dates throughout their life cycle