FDA.reportPublic FDA data

NA

Primary DI
05415067037275
Brand
NA
Company
ST. JUDE MEDICAL, INC.
Model
DS2A088
Catalog number
DS2A088
Device description
Suture Sleeve
Published
2022-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960013118

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960013118TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSABBOTT MEDICAL1997-06-20NVN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067037275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067037275054150670372755415067037275

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead suture sleeveA small device with a hollow centre that functions as a channel for a pacing or defibrillation lead(s), and is positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the pacemaker or defibrillator system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Storage excursions permitted from 59°- 86° F (15°- 30°C).
Special Storage Condition, Specify00Store at room temperature 25° C (77°F)
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

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Primary DI, Brand, Company table
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08031527019802VegaMICROPORT CRM SRLNVN2023-06-23
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05415067046321UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
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05415067046345UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
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00763000130794SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
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