|
Device | Spinal Cord Stimulation (SCS) |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S164 |
Date Received | 05/07/2020 |
Decision Date | 06/04/2020 |
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 Addition of an alternate tier-3 supplier for ASTM Grade-l Titanium material used in the manufacture for implantable pulse generators. |