ASCENDA INTRATHECAL CATHETERS AND KITS

FDA premarket approval P860004/S257 · decided 2016-09-27

Approval details

PMA number

P860004

Supplement

S257

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

ASCENDA INTRATHECAL CATHETERS AND KITS

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2016-06-30

Decision date

2016-09-27

Days to decision

89 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for labeling changes for Medtronics Ascenda Intrathecal Catheter and Revision Kit including: Implant Manuals Catheter Length Measurement; Implant Manuals Materials Table; Implant Manuals Verb change; Implant Manuals Reference to Model 8784 Kit added; Implant Manuals Other clarification, administrative and style changes; Package Labels Catheter Length Measurements; Package Labels Addition of symbols; Package Labels Other minor changes. These changes impact the manuals associated with the

510(k) clearances by this applicant