CLIP PENDITURE LAAC35

CLIP PENDITURE LAAC35
Penditure™ - LAAC35

Device Description

A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Environmental Conditions

Special Storage Condition, Specify

Store in a cool, dry place.

Device Sizes

Clip size 35 mm

Clip size 35 mm

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PZX

Device Name: Left Atrial Appendage Clip, Implantable

Device Class: 2

Physical State: A clip-like device that compresses the left atrial appendage.

Definition: Intended to occlude the left atrial appendage.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Epicardially applied during a concomitant surgical procedure to physically occlude the left atrial appendage.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Left atrial appendage of the heart.

Regulation Number: 878.4300

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 00763000791445

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A