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FDA PMA

neuromodulator for obesity

PMA Number: P130019 · 2016-12-22

ApplicantReshape Lifesciences, Inc.
Decision Date2016-12-22
PMA NumberP130019
Product CodePIM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

neuromodulator for obesity is a medical device manufactured by Reshape Lifesciences, Inc.. It received FDA Premarket Approval (PMA) on 2016-12-22 under PMA number P130019. The device is classified under FDA product code PIM. It was reviewed by the GU 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 neuromodulator for obesity?

neuromodulator for obesity is a medical device that received FDA Premarket Approval (PMA) on 2016-12-22. It is manufactured by Reshape Lifesciences, Inc.. The PMA number is P130019.

When did neuromodulator for obesity receive FDA PMA approval?

neuromodulator for obesity received FDA PMA approval on 2016-12-22, under approval number P130019.

What company makes neuromodulator for obesity?

neuromodulator for obesity is manufactured by Reshape Lifesciences, 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 neuromodulator for obesity?

The FDA product code for neuromodulator for obesity is PIM.

What FDA device class is neuromodulator for obesity?

neuromodulator for obesity is classified as Class III by the FDA.

Official Source

View on FDA Database →

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

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