PMA P010032S148
- Device
- Proclaim SCS Neurostimulation System FW
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S148
- Product code
- LGW
- Decision date
- 2019-05-03
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for an update to the firmware version to v1.3 for the legally marketed family Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generators.
Current openFDA PMA Record#
- Device
- Proclaim SCS Neurostimulation System FW
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S148
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-05-03
- Decision code
- APPR
- Date received
- 2019-01-23
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the firmware version to v1.3 for the legally marketed family Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generators.