Identity
- Trade Name
- OPTIMIZER® FDA UDI
- Generic Name
- Cardiac contractility modulation system pulse generator FDA UDI
- Device Name
- OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug FDA UDI
- Model / Reference
- CCM X10 FDA UDI
- Description
- OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug FDA UDI
Identifiers
- Catalog Number
- 10-B411-3-US FDA UDI
- Primary DI / UDI-DI
- 00810003380005 FDA UDI
- PMA Number
- P180036 FDA UDI
- FDA Product Code
- QFV FDA UDI
- GMDN Term
- Cardiac contractility modulation system pulse generator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac contractility modulation system pulse generator
Optimizer® by Impulse Dynamics (usa) Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac contractility modulation system pulse generator.
- OPTIMIZER — Impulse Dynamics (usa) Inc. · Class III
- OPTIMIZER — Impulse Dynamics (usa) Inc. · Class III
- OPTIMIZER™ — Impulse Dynamics (usa) Inc. · Class III
Cleared under the same submission
P180036 also covers:
- Guardio — Impulse Dynamics (usa) Inc.
- Intelio — Impulse Dynamics (usa) Inc.
- OMNI™ II — Impulse Dynamics (usa) Inc.
- OPTIMIZER — Impulse Dynamics (usa) Inc.
- OPTIMIZER — Impulse Dynamics (usa) Inc.
- OPTIMIZER® — Impulse Dynamics (usa) Inc.
- OPTIMIZER™ — Impulse Dynamics (usa) Inc.
- OPTIMIZER™ — Impulse Dynamics (usa) Inc.
- Vesta — Impulse Dynamics (usa) Inc.
- Vesta — Impulse Dynamics (usa) Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Impulse Dynamics (usa) Inc.
Sources (1)
- FDA UDI 2c78fead-0009-44a9-ae02-ae2b66459c27 37 fields · synced May 30, 2026