|
Device | EXTERNAL PULSE GENERATOR, 2 PORT HEADER |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S103 |
Date Received | 10/06/2015 |
Decision Date | 11/05/2015 |
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 IMPLEMENTATION OF UPDATES TO THE TEST EQUIPMENT AND MEASUREMENT TECHNIQUES USED DURING THE MANUFACTURING PROCESS OF THE MICRO HDMI CONNECTOR OF THE SJM EPG HEADER MODEL 3032. |