DEVICE: PALMAZ Balloon Expandable Stent (10705032064736)

Device Identifier (DI) Information

PALMAZ Balloon Expandable Stent
P294
In Commercial Distribution
P294
CORDIS CORPORATION
10705032064736
GS1

1
806136177 *Terms of Use
No description.
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple peripheral artery stent, bare-metal A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.
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FDA Product Code

[?]
Product Code Product Code Name
MAF STENT, CORONARY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P890017 015
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Do not use if package is damanged
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

165b960a-ea46-46d5-aa4b-c953b36482cd
July 06, 2018
3
May 07, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20705032057285 4 10705032064736 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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