- Device
- Eon Mini™ IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S182
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-11-04
- Decision code
- OK30
- Date received
- 2021-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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