DEVICE: ACUITY™ X4 Spiral L (00802526524592)

Device Identifier (DI) Information

ACUITY™ X4 Spiral L
4677
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
00802526524592
GS1

1
106295384 *Terms of Use
Pace/Sense Lead
CLOSE

Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
Yes
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?
35223 Endocardial/interventricular septal pacing lead
An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LWP Implantable pulse generator, pacemaker (non-CRT)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P010012 398
P010012 416
P010012 423
P010012 437
P010012 453
P010012 484
P010012 494
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 86 cm Length
CLOSE

Device Record Status

9f6b1b1b-c4cb-425d-b49e-e4a8270ee2f8
March 20, 2024
7
February 25, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE