|
Device | IMPLANTABLE PULSE GENERATORS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S049 |
Date Received | 03/27/2012 |
Decision Date | 04/25/2012 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement STERILIZATION MANUFACTURING PROCESS CHANGES FOR ST. JUDE MEDICAL NEUROMODULATION DIVISION PRODUCTS. |