Catalog Number

9-PFO-018

Brand Name

Amplatzer™

Version/Model Number

PFO Occluder

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MLV

Product Code Name

Transcatheter septal occluder

Public Device Record Key

cc871aea-2ed4-4254-9800-c9e7916fe829

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

November 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-