DEVICE: PulseSelect™ (00763000617752)
Device Identifier (DI) Information
PulseSelect™
PSRC101
In Commercial Distribution
MEDTRONIC, INC.
PSRC101
In Commercial Distribution
MEDTRONIC, INC.
REMOTE CONTROL PSRC101 PFA 25FT US
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? |
---|---|---|---|---|
66867 | Cardiac irreversible electroporation system remote control |
A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to allow a healthcare provider to control the operational functions of a cardiac irreversible electroporation system and its components (e.g., cardiac tissue ablation catheter) from a distance via a connected cable.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P230017 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
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Length: 25.0 Feet |
Device Record Status
90b3d627-c1c0-4c6d-84a1-de91fae77c13
February 13, 2024
1
February 05, 2024
February 13, 2024
1
February 05, 2024
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(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com