|
Device | PADDLE LEAD KITS DFU |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S035 |
Date Received | 10/21/2010 |
Decision Date | 11/17/2010 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES THAT CLARIFY THE SURGICAL PROCEDURES USED TO IMPLANT PADDLE LEADS. |