PMA P150004S038

Device
Dorsal Root Ganglion Stimulator for Pain Relief
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S038
Product code
PMP
Decision date
2020-05-30
Generic name
Dorsal root ganglion stimulator for pain relief
Approval order statement
Alternative bacterial endotoxin test method.

Current openFDA PMA Record#

Device
Dorsal Root Ganglion Stimulator for Pain Relief
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S038
Product code
PMP
Generic name
Dorsal root ganglion stimulator for pain relief
Decision date
2020-05-30
Decision code
OK30
Date received
2020-04-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternative bacterial endotoxin test method.