DEVICE: Gallant™ (05415067050052)
Device Identifier (DI) Information
Gallant™
CDHFA500D
In Commercial Distribution
CDHFA500D
ST. JUDE MEDICAL, INC.
CDHFA500D
In Commercial Distribution
CDHFA500D
ST. JUDE MEDICAL, INC.
HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV
Device Characteristics
| MR Conditional | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47270 | Cardiac resynchronization therapy implantable defibrillator |
An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| DXY | implantable pacemaker Pulse-generator |
| LWO | Pulse-generator, single chamber, sensor driven, implantable |
| PNJ | Leadless pacemaker |
| LWP | Implantable pulse generator, pacemaker (non-CRT) |
| LWS | Implantable cardioverter defibrillator (non-CRT) |
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit |
| Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
| Handling Environment Temperature: between -20 and 60 Degrees Celsius |
| Special Storage Condition, Specify: Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6fb70503-0851-4d66-8a58-27b5404de76f
February 19, 2025
1
February 11, 2025
February 19, 2025
1
February 11, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com