DEVICE: Open Pivot™ (00643169333666)
Device Identifier (DI) Information
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? |
---|---|---|---|---|
60423 | Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft |
An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LWQ | HEART-VALVE, MECHANICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P990046 | 005 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Tissue Annulus 21 MM |
Device Record Status
c9ac2712-6a47-4630-b6f2-b26f0bc93e6d
February 05, 2021
4
September 23, 2014
February 05, 2021
4
September 23, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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