ACTIVA® SC

Basic Information

• Brand Name: ACTIVA® SC
• Primary DI: 00613994761064
• Version / Model: 37602
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-03
• Public Version: 4
• Public Version Date: 2023-07-10
• Public Version Status: Update
• Public Device Record Key: d1e2c566-75bc-463a-8176-0c333d2651df
• Distribution End Date: 2023-05-24

Device Description

INS 37602 ACTIVA SC NON PARYLENE US

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	Unknown		3
NHL	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS	Unknown		3
MRU	implanted subcortical electrical Stimulator (motor disorders)	Unknown		f
PJS	Stimulator, electrical, implanted, for essential tremor	Unknown		3
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
37307	Deep brain electrical stimulation system	An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994761064	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960009	149

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 126 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -18 – 52 Degrees Celsius