DEVICE: nGEN Generator (10846835018080)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
60784 | Cardiac radio-frequency ablation system generator |
An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPB | Cardiac ablation percutaneous catheter |
OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P010068 | 067 |
P030031 | 122 |
P040036 | 084 |
P950005 | 082 |
P990025 | 067 |
P990071 | 051 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Dry |
Special Storage Condition, Specify: Keep out of direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7bf94063-b51e-42ac-80ea-c024d889d3e1
January 16, 2025
2
August 18, 2022
January 16, 2025
2
August 18, 2022
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 |
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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(800)729-9010
RA-BWIUS-Complaints@its.jnj.com
RA-BWIUS-Complaints@its.jnj.com