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FDA PMA

Drug-coated peripheral transluminal angioplasty catheter

PMA Number: P190008 · 2026-05-01

ApplicantMedtronic Vascular, Inc.
Decision Date2026-05-01
PMA NumberP190008
Product CodePRC
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Drug-coated peripheral transluminal angioplasty catheter is a medical device manufactured by Medtronic Vascular, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-01 under PMA number P190008. The device is classified under FDA product code PRC. It was reviewed by the CV advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Drug-coated peripheral transluminal angioplasty catheter?

Drug-coated peripheral transluminal angioplasty catheter is a medical device that received FDA Premarket Approval (PMA) on 2026-05-01. It is manufactured by Medtronic Vascular, Inc.. The PMA number is P190008.

When did Drug-coated peripheral transluminal angioplasty catheter receive FDA PMA approval?

Drug-coated peripheral transluminal angioplasty catheter received FDA PMA approval on 2026-05-01, under approval number P190008.

What company makes Drug-coated peripheral transluminal angioplasty catheter?

Drug-coated peripheral transluminal angioplasty catheter is manufactured by Medtronic Vascular, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Drug-coated peripheral transluminal angioplasty catheter?

The FDA product code for Drug-coated peripheral transluminal angioplasty catheter is PRC.

What FDA device class is Drug-coated peripheral transluminal angioplasty catheter?

Drug-coated peripheral transluminal angioplasty catheter is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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