DEVICE: Arctic Front Advance Pro™ (00763000088637)
Device Identifier (DI) Information
Arctic Front Advance Pro™
AFAPRO28
Not in Commercial Distribution
MEDTRONIC, INC.
AFAPRO28
Not in Commercial Distribution
MEDTRONIC, INC.
CATH AFAPRO28 AFA PRO 28MM US PB
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
60720 | Cardiac cryosurgical system catheter |
A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P100010 | 084 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Dry |
Handling Environment Temperature: between -31 and 113 Degrees Fahrenheit |
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Catheter shaft size 10.5 Fr |
Device Size Text, specify: Catheter tip width 28 mm |
Length: 95.0 Centimeter |
Device Record Status
719b5cc0-b4b5-4986-9942-34dd67e8cbed
July 06, 2023
2
March 23, 2019
July 06, 2023
2
March 23, 2019
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)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com