FDA.reportPublic FDA data

PMA P150004S052

Device
Proclaim DRG IPG
Applicant
ABBOTT MEDICAL
Product code
PMP
Decision date
2023-11-27
Generic name
Dorsal root ganglion stimulator for pain relief
Approval order statement
This supplement requested approval for qualifying an alternate supplier (ProMed) for the existing components split septum and header seals of the ProClaim Dorsal Root Ganglion (DRG) Stimulation Implantable Pulse Generator (IPG).

Current openFDA PMA Record#

Device
Proclaim DRG IPG
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S052
Product code
PMP
Generic name
Dorsal root ganglion stimulator for pain relief
Decision date
2023-11-27
Decision code
APPR
Date received
2021-09-10
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
This supplement requested approval for qualifying an alternate supplier (ProMed) for the existing components split septum and header seals of the ProClaim Dorsal Root Ganglion (DRG) Stimulation Implantable Pulse Generator (IPG).