PMA P150004S036

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S036
Product code: PMP
Decision date: 2020-05-06
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Implement an updated Helium Leak Test System Software used during assembly of Orion family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs).

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S036
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2020-05-06
Decision code: OK30
Date received: 2020-04-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement an updated Helium Leak Test System Software used during assembly of Orion family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs).