PMA

P120020: SUPERA PERIPHERAL STENT SYSTEM

FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · Abbott Vascular (Idef Technologies Inc)

Key facts

PMA number P120020
Trade name SUPERA PERIPHERAL STENT SYSTEM
Generic name STENT, SUPERFICIAL FEMORAL ARTERY
Applicant Abbott Vascular (Idef Technologies Inc)
Owner/operator ABBOTT LABORATORIES
Product code NIP
Approval date Mar 28, 2014
Docket number 14M-0434
Notice date Apr 21, 2014
Establishment registration 2939561
FEI number 3004635528

At a glance

  • 10–99 Supplements
  • Mar 20, 2026 Latest supplement decision
  • No Withdrawn
  • Yes Summary of safety and effectiveness on file
  • None UDI device identifiers (GUDID)
  • None MAUDE adverse event reports
  • None Recall events

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA approvals

Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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