PMA P150004S033

Device
Proclaim DRG IPG
Applicant
ABBOTT MEDICAL
Product code
PMP
Decision date
2020-06-05
Generic name
Dorsal root ganglion stimulator for pain relief
Approval order statement
Approval for cybersecurity software updates for the Clinician Programmer (CP) and Patient Controller (PC).

Current openFDA PMA Record#

Device
Proclaim DRG IPG
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S033
Product code
PMP
Generic name
Dorsal root ganglion stimulator for pain relief
Decision date
2020-06-05
Decision code
APPR
Date received
2019-11-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for cybersecurity software updates for the Clinician Programmer (CP) and Patient Controller (PC).