Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MODEL 7421 ITREL(R), 7424 ITREL(R) II, 7425 ITREL(R) III AND MEDEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S045 |
Date Received | 01/24/2000 |
Decision Date | 06/13/2000 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE FOR MODEL 7421 ITREL(R), 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) DEVICES. THESE DEVICES ARE INDICATED "AS N AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND LIMBS, INCLUDING-CHRONIC AND INTRACTABLE UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK... |
|
|