FDA Approved
Existing Device (Modification)
Pathway: PMA
CentriMag Circulatory Support System
Applicant:
Abbott
ABT
Statutory Profile
Legal Standard:
Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)
Product Code:
DSQ
Review Panel:
Cardiovascular
21 CFR Regulation:
Unspecified
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
Lucy Tan
Role: US_AGENT
📞 925-4169778
✉️ lucy.tan@abbott.com
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