PMA P150004S019
- Device
- Proclaim DRG IPG
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S019
- Product code
- PMP
- Decision date
- 2018-01-10
- Classification
- Dorsal Root Ganglion Stimulator For Pain Relief
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Approval order statement
- Alternate supplier manufacturing location for the drilling process for the Bluetooth (BLE) antenna (this also included new equipment models). The BLE antenna is a component of the spinal cord stimulation (SCS) and deep brain stimulation (DBS) implantable pulse generator (IPGs) headers.
Current openFDA PMA Record#
- Device
- Proclaim DRG IPG
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S019
- Product code
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Decision date
- 2018-01-10
- Decision code
- OK30
- Date received
- 2017-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier manufacturing location for the drilling process for the Bluetooth (BLE) antenna (this also included new equipment models). The BLE antenna is a component of the spinal cord stimulation (SCS) and deep brain stimulation (DBS) implantable pulse generator (IPGs) headers.