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FDA PMA

Agent, absorbable hemostatic, collagen based

PMA Number: N17600 · 2026-05-11

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date2026-05-11
PMA NumberN17600
Product CodeLMF
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Agent, absorbable hemostatic, collagen based is a medical device manufactured by Davol Inc., Sub. C. R. Bard, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-11 under PMA number N17600. The device is classified under FDA product code LMF. It was reviewed by the SU 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 G. It is regulated under 21 CFR Part 8. 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 Agent, absorbable hemostatic, collagen based?

Agent, absorbable hemostatic, collagen based is a medical device that received FDA Premarket Approval (PMA) on 2026-05-11. It is manufactured by Davol Inc., Sub. C. R. Bard, Inc.. The PMA number is N17600.

When did Agent, absorbable hemostatic, collagen based receive FDA PMA approval?

Agent, absorbable hemostatic, collagen based received FDA PMA approval on 2026-05-11, under approval number N17600.

What company makes Agent, absorbable hemostatic, collagen based?

Agent, absorbable hemostatic, collagen based is manufactured by Davol Inc., Sub. C. R. Bard, 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 Agent, absorbable hemostatic, collagen based?

The FDA product code for Agent, absorbable hemostatic, collagen based is LMF.

What FDA device class is Agent, absorbable hemostatic, collagen based?

Agent, absorbable hemostatic, collagen based 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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