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K Number
K014129
Device Name
PROMOGRAN MATRIX WOUND DRESSING
Manufacturer
JOHNSON & JOHNSON MEDICAL, LTD.
Date Cleared
2002-02-14

(59 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K982597
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PROMOGRAN Matrix Wound Dressing is intended for the management of exuding wounds including:

  • Diabetic ulcers .
  • . Venous ulcers
  • Pressure ulcers .
  • Ulcers caused by mixed vascular etiologies ●
  • Full thickness and partial thickness wounds .
  • Donor sites and other bleeding surface wounds ●
  • Abrasions ●
  • Traumatic wounds healing by secondary intention ●
  • Dehisced surgical wounds ●
Device Description

PROMOGRAN Matrix Wound Dressing is a sterile primary dressing comprised of a freeze-dried composite of 55% collagen and 45% oxidised regenerated cellulose. (Ratios are presented as weight-to-weight).

AI/ML Overview

This document is a 510(k) summary for the PROMOGRAN Matrix Wound Dressing. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor any of the specific details requested in the prompt (e.g., sample sizes, expert qualifications, ground truth methods, or MRMC studies).

The document is a regulatory submission for premarket notification, focusing on establishing equivalence for marketing purposes. It highlights biocompatibility studies showing the device to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic, but these are general safety assessments, not performance criteria with associated studies as requested.

N/A