DEVICE: ACCOLADE™ MRI EL DR (00802526559266)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
ACCOLADE™ MRI EL DR
L331
In Commercial Distribution
L331
BOSTON SCIENTIFIC CORPORATION
00802526559266
GS1

1
106295384 *Terms of Use
Pacemaker
CLOSE

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?
47265 Dual-chamber implantable pacemaker, rate-responsive
A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.
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 [?]
P150012 000
P150012 004
P150012 013
P150012 021
P150012 033
P150012 034
P150012 042
P150012 060
P150012 068
P150012 080
P150012 100
P150012 112
P150012 129
P150012 132
P150012 134
P150012 156
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
No Device Sizes
CLOSE

Device Record Status
e026c323-e09c-4f5e-9461-4d97fbc54c86
June 28, 2024
12
May 10, 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