GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

FDA premarket approval P010032/S090 · decided 2015-03-04

Approval details

PMA number

P010032

Supplement

S090

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2014-12-15

Decision date

2015-03-04

Days to decision

79 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR A DESIGN CHANGE TO THE STYLET MODELS THAT ARE USED WITHSJM SCS SYSTEMS; SPECIFICALLY, COATING THE STYLETS WITH A PFOA-FREE PTFE, RESULTING IN GENERATION 3 OF THE STYLETS. THIS SUPPLEMENT ALSO REQUESTED APPROVAL FOR A MANUFACTURING CHANGE TO TIGHTEN THE TOLERANCES ON THE TOOLING MANDREL USED TO MANUFACTURE THE ASSOCIATED LEAD MODELS.

510(k) clearances by this applicant