DEVICE: Serena™ Quad CRT-P MRI SureScan™ (00643169735668)

Device Identifier (DI) Information

Serena™ Quad CRT-P MRI SureScan™
W4TR02
In Commercial Distribution

MEDTRONIC, INC.
00643169735668
GS1

1
006261481 *Terms of Use
CRTP W4TR02 SERENA QUAD CRTP MRI US
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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?
47263 Cardiac resynchronization therapy implantable pacemaker
A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P010015 317
P010015 338
P010015 340
P010015 391
P010015 399
P010015 411
P010015 439
P010015 463
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 131 Degrees Fahrenheit
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Clinically Relevant Size

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

0114b515-d57e-484b-95ae-c58f8f646d64
November 21, 2022
9
June 18, 2017
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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
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Secondary DI

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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