OPTIMIZER

Basic Information

• Brand Name: OPTIMIZER
• Primary DI: 00810003380142
• Version / Model: Lite
• Catalog Number: 10-B502-3-XX
• Company Name: Impulse Dynamics (usa) Inc.
• Labeler DUNS: 878519342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-26
• Public Version: 1
• Public Version Date: 2024-03-05
• Public Version Status: New
• Public Device Record Key: d67c527b-d629-48b2-87ce-5c36c3a32b05

Device Description

OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Lite Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFV	Implantable Pulse Generator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47468	Cardiac contractility modulation system pulse generator	A hermetically-sealed, battery-powered device implanted beneath the skin to produce electrical signals delivered to the heart via implantable cardiac pacing leads during the ventricular absolute refractory period (ARP) to enhance the strength of the heart [cardiac contractility modulation (CCM)], typically as treatment for heart failure. The device is programmed by and transmits cardiac diagnostic data to an external programmer telemetrically.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810003380142	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P180036	021

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit