SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS

FDA premarket approval P010032/S119 · decided 2016-06-28

Approval details

PMA number

P010032

Supplement

S119

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2016-06-13

Decision date

2016-06-28

Days to decision

15 days

Decision code

OK30

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.

510(k) clearances by this applicant