CAPSURE®SP NOVUS

GUDID 00643169590700

LEAD 509285 CAPSURE SP US BI SIL VENT

MEDTRONIC, INC.

Endocardial pacing lead

• Primary Device ID: 00643169590700
• NIH Device Record Key: f8ba69cd-2ce2-4d60-b72e-3a75b313aed0
• Commercial Distribution Discontinuation: 2018-04-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CAPSURE®SP NOVUS
• Version Model Number: 509285
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169590700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850089

FDA Product Code

• DTB: permanent pacemaker Electrode

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-14

On-Brand Devices [CAPSURE®SP NOVUS]

• 00613994250230: LEAD 559445 FPA BI SIL ATR STER US
• 00613994250223: LEAD 559453 FPA BI SIL ATR STER US
• 00643169590762: LEAD 559458 CAPSURE SP US BI SIL ATRL
• 00643169590755: LEAD 559453 CAPSURE SP US BI SIL ATRL
• 00643169590748: LEAD 559445 CAPSURE SP US BI SIL ATRL
• 00643169590731: LEAD 5592-53 CAPSURE SP US BI SIL ATRL
• 00643169590724: LEAD 5592-45 CAPSURE SP US BI SIL ATRL
• 00643169590700: LEAD 509285 CAPSURE SP US BI SIL VENT
• 00643169590694: LEAD 5092-65 CAPSURE SP US BI SIL VENT
• 00643169590687: LEAD 5092-58 CAPSURE SP US BI SIL VENT
• 00643169590670: LEAD 5092-52 CAPSURE SP US BI SIL VENT
• 00643169590663: LEAD 5092-45 CAPSURE SP US BI SIL VENT
• 00681490135733: LEAD 5592-53 STEROID BIP SILICONE ATRL
• 00681490135696: LEAD 5592-45 CAPSURE SP NOVUS US
• 00681490125109: LEAD 5092-58 BIP SILICONE VENT STEROID
• 00681490125048: LEAD 5092-52 BIP SILICONE VENT STEROID
• 00681490114974: LEAD 4592-53 BI HYBR CAPSURE US PAS 53CM
• 00681490114943: LEAD 4592-45 CAPSURE BIP HYB DPLS PAS
• 00681490110778: LEAD 4092-65 CAPSURE SP BIP HYBRID
• 00681490110716: LEAD 4092-58 CAPSURE BI HYBRID 58CM US
• 00681490110655: LEAD 4092-52 CAPSURE SP NOVUS US