Home
Forms Library
PM DEVICES INC - accessdata fda

PM DEVICES INC - accessdata fda 2025

PM DEVICES INC - accessdata fda Preview on Page 1

Show details

4.8 out of 5

49 votes

The document is a 510(k) premarket notification for the PeriPatch Sheet, a surgical patch made from processed bovine pericardium intended for intra-cardiac repair and soft tissue deficiency repair. It outlines the device's description, predicate devices, safety and effectiveness, and intended use. The PeriPatch Sheet is claimed to be substantially equivalent to previously cleared products, with similar materials, technological characteristics, and manufacturing processes.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

The easiest way to edit PM DEVICES INC - accessdata fda in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Adjusting paperwork with our extensive and user-friendly PDF editor is simple. Make the steps below to fill out PM DEVICES INC - accessdata fda online quickly and easily:

Log in to your account. Log in with your credentials or register a free account to try the product before choosing the subscription.
Upload a form. Drag and drop the file from your device or add it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit PM DEVICES INC - accessdata fda. Effortlessly add and highlight text, insert images, checkmarks, and signs, drop new fillable areas, and rearrange or delete pages from your document.
Get the PM DEVICES INC - accessdata fda accomplished. Download your adjusted document, export it to the cloud, print it from the editor, or share it with other participants using a Shareable link or as an email attachment.

Make the most of DocHub, one of the most easy-to-use editors to rapidly manage your documentation online!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

How to see if a company is registered with the FDA?

0:28 1:45 Now keep in mind not all companies are required to register with the FDA. So if you dont see yourMoreNow keep in mind not all companies are required to register with the FDA. So if you dont see your company listed Dont Panic. It doesnt mean theyre selling you Goods.

What is a premarket approval?

Overview. A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional, Special, and Abbreviated.

What is the difference between premarket notification and 510K?

Whats the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

How do you check if a device is FDA approved?

Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA. To search for FDA-approved or FDA-cleared products by device name or company name: Go to the Devices@FDA Database.

What is the difference between 510K clearance and approval?

A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application.

What is FDA PM?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

PM DEVICES INC - accessdata fda 2025

Here's how it works