FDA Cleared
Existing Device (Modification)
Pathway: 510K
Arctic Sun Neonatal ArcticGel Pad
Applicant:
Medivance, Inc.
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
DWJ
Review Panel:
Cardiovascular
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-09-30
Decision Date:
2026-10-30
Total Review Duration:
30 calendar days (30 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Monica Williams
Role: SUBMITTER_CONTACT
Notice a discrepancy or outdated information on this record?
Report to support@fdacleared.org