|
Device | Spinal Cord Stimulation (SCS) Leads |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S209 |
Date Received | 01/05/2024 |
Decision Date | 02/02/2024 |
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 to relocate the SCS Leads and DBS Infinity Leads packaging operations from an ISO Class 7 clean access environment to In-line Packaging in an ISO Class 8 clean access environment at your Plano, Texas manufacturing facility |