Ablapak - The Ablapak is he single use kit of consumables - EDAP-TMS FRANCE

Duns Number:383113362

Device Description: The Ablapak is he single use kit of consumables to support a single patient procedure usin The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.

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More Product Details

Catalog Number

-

Brand Name

Ablapak

Version/Model Number

TMS 227710

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K153023

Product Code Details

Product Code

PLP

Product Code Name

High Intensity Ultrasound System For Prostate Tissue Ablation

Device Record Status

Public Device Record Key

823d77db-07dc-466b-a9bc-008f3b949f2a

Public Version Date

July 09, 2018

Public Version Number

1

DI Record Publish Date

June 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EDAP-TMS FRANCE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15