OPTIMIZER 10-B502-3-XX
GUDID 00810003380142
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
Impulse Dynamics (usa) Inc.
Cardiac contractility modulation system pulse generator| Primary Device ID | 00810003380142 |
| NIH Device Record Key | d67c527b-d629-48b2-87ce-5c36c3a32b05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTIMIZER |
| Version Model Number | Lite |
| Catalog Number | 10-B502-3-XX |
| Company DUNS | 878519342 |
| Company Name | Impulse Dynamics (usa) Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810003380142 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P180036
FDA Product Code
| QFV | Implantable Pulse Generator |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-05 |
| Device Publish Date | 2024-02-26 |
On-Brand Devices [OPTIMIZER]
| 00810003380098 | OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure System consi |
| 00810003380142 | OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure System consists of |
Trademark Results [OPTIMIZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIMIZER 98404259 not registered Live/Pending |
SKS Industries, Inc. 2024-02-13 |
 OPTIMIZER 90510200 not registered Live/Pending |
Enerco Group, Inc. 2021-02-04 |
 OPTIMIZER 90239421 not registered Live/Pending |
Optimatics Pty Ltd 2020-10-07 |
 OPTIMIZER 88781257 not registered Live/Pending |
Matthew Bulmer 2020-01-31 |
 OPTIMIZER 88352470 not registered Live/Pending |
Conmed Corporation 2019-03-22 |
 OPTIMIZER 88048884 not registered Dead/Abandoned |
Encapsulation Technologies, Inc. 2018-07-23 |
 OPTIMIZER 87750751 not registered Live/Pending |
Global Marine Networks, LLC 2018-01-10 |
 OPTIMIZER 87191841 5204394 Live/Registered |
Todd Williams 2016-10-03 |
OPTIMIZER 87191841 5204394 Live/Registered |
Cynthia Williams 2016-10-03 |
 OPTIMIZER 86717298 not registered Dead/Abandoned |
FLUIDMASTER, INC. 2015-08-06 |
 OPTIMIZER 86392126 4723557 Live/Registered |
SJB BRANDS, LLC 2014-09-11 |
 OPTIMIZER 86019691 4973519 Live/Registered |
MINDRAY DS USA, INC. 2013-07-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.