ASCENDA INTRATHECAL CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR

FDA premarket approval P860004/S250 · decided 2016-09-09

Approval details

PMA number

P860004

Supplement

S250

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ASCENDA INTRATHECAL CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR

Generic name

Pump, infusion, implanted, programmable

Applicant

Medtronic, Inc.

Date received

2016-05-31

Decision date

2016-09-09

Days to decision

101 days

Decision code

APPR

Product code

LKK

Advisory committee

General Hospital

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for the addition of a low-PFOA (perfluorooctanoic acid) polytetrafluoroethylene (PTFE) coating to the Anchor Dispenser Tool (ADT) to address customer complaints of difficulty deploying the Ascenda anchor from the Anchor Dispenser Tool; the addition of the flare to the hypotube; the updated materials list in the Ascenda Implant Manual and minor changes to dimension tolerances on the Anchor Dispenser Tool.

510(k) clearances by this applicant