GENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG

FDA premarket approval P010032/S081 · decided 2014-09-16

Approval details

PMA number

P010032

Supplement

S081

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2014-06-11

Decision date

2014-09-16

Days to decision

97 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR A MATERIAL CHANGE TO THE PORT PLUG USED IN THE APPROVED IMPLANTED PULSE GENERATORS (IPG MODELS 3608, 3688, 3716, 3788 AND 3789). THE PORT PLUG IS AN ACCESSORY TO THE IPG USED TO BLOCK TISSUE INGRESS INTO THE IPG HEADER. WHEN IMPLANTING ONLY A SINGLE LEAD IN AN IPG CONTAINING DUAL LEAD PORTS, THE PORT PLUG IS INSERTED INTO THE UNUSED LEAD PORT AND SECURED BY TIGHTENING THE SETSCREW ONTO THE PORT PLUG.

510(k) clearances by this applicant