Solia CSP S 53 468461

GUDID 04035479177058

BIOTRONIK SE & Co. KG

Endocardial/interventricular septal pacing lead

• Primary Device ID: 04035479177058
• NIH Device Record Key: 4a5eb5bd-6cf9-438d-b69e-612b134b9645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solia CSP S 53
• Version Model Number: 468461
• Catalog Number: 468461
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479177058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950037

FDA Product Code

• NVN: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-25
• Device Publish Date: 2026-02-17

Devices Manufactured by BIOTRONIK SE & Co. KG

• 04035479177041 - Solia CSP S 60: 2026-02-25
• 04035479177058 - Solia CSP S 53: 2026-02-25
• 04035479177058 - Solia CSP S 53: 2026-02-25
• 04035479189235 - SW HMSC 3.65: 2026-01-28
• 04035479188689 - SW HMSC 3.63: 2025-05-15
• 04035479179687 - NEO: 2025-04-11
• 04035479179694 - PSW: 2025-04-11
• 04035479185817 - Neuro CP app 2300.U: 2025-04-04
• 04035479188733 - Neuro PR app 2400.U: 2025-04-04