Solia CSP S 60

Basic Information

• Brand Name: Solia CSP S 60
• Primary DI: 04035479177041
• Version / Model: 468460
• Catalog Number: 468460
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-17
• Public Version: 1
• Public Version Date: 2026-02-25
• Public Version Status: New
• Public Device Record Key: 1dece100-4dc8-4843-bb5f-20d880625a7a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NVN	Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479177041	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P950037	280

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length: 60 cm
Device Size Text, specify			Diameter (outer): 1.9 mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 131 Degrees Fahrenheit