|
Device | Eon Mini™ IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S182 |
Date Received | 10/05/2021 |
Decision Date | 11/04/2021 |
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 Manufacturing site transfer of the printed circuit boards (PCBs) subassemblies used in several implantable pulse generators (IPGs) and their external accessories from its current site in 253 Financial Blvd. Liberty SC 29657, USA to another approved Abbott facility located in 8300 E. Pacesetter Way Scottsdale AZ 85255, USA |