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