DEVICE: Tendril MRI™ (05414734504638)
Device Identifier (DI) Information
Tendril MRI™
LPA1200M-58
In Commercial Distribution
LPA1200M-58
ST. JUDE MEDICAL, INC.
LPA1200M-58
In Commercial Distribution
LPA1200M-58
ST. JUDE MEDICAL, INC.
Pacing Lead
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P140033 | 000 |
| P140033 | 019 |
| P140033 | 023 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 20 and 25 Degrees Celsius |
| Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify: Storage excursions permitted from 59°- 86° F (15°- 30°C). |
| Handling Environment Temperature: between -5 and 50 Degrees Celsius |
| Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 58 Centimeter |
Device Record Status
caeeae32-3e5f-4992-90df-57ac31da662d
March 20, 2024
7
February 07, 2017
March 20, 2024
7
February 07, 2017
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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(855)478-5833
customerservice@sjm.com
customerservice@sjm.com