MODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS

FDA premarket approval P840001/S052 · decided 2001-08-03

Approval details

PMA number

P840001

Supplement

S052

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

Medtronic Neuromodulation

Date received

2001-04-10

Decision date

2001-08-03

Days to decision

115 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE FROM "CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS" TO "CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS". THE INDICATION STATEMENT HAS BEEN REVISED TO STATE "THE MEDTRONIC [TRADE NAME] SYSTEM IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RAD

510(k) clearances by this applicant