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Eon Mini™ IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P

FDA premarket approval P010032/S182 · decided 2021-11-04

Approval details

PMA number
P010032
Supplement
S182
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
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
Date received
2021-10-05
Decision date
2021-11-04
Days to decision
30 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
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

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