PMA P010032S125
- Device
- Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S125
- Product code
- LGW
- Decision date
- 2017-07-21
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for 1) Addition of a Proclaim IPG device models 3661 and 3663, each with a header that is compatible with Medtronic (MDT) leads; 2) Sustaining enhancements to the firmware (FW 1.1 – new version of firmware; 3) Enabling the Burst stimulation feature (marketed as BurstDR stimulation) for Proclaim IPGs with MDT headers and 4) Inclusion of the Lead & Extension Insertion Tool (LEIT).
Current openFDA PMA Record#
- Device
- Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S125
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-07-21
- Decision code
- APPR
- Date received
- 2016-10-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for 1) Addition of a Proclaim IPG device models 3661 and 3663, each with a header that is compatible with Medtronic (MDT) leads; 2) Sustaining enhancements to the firmware (FW 1.1 – new version of firmware; 3) Enabling the Burst stimulation feature (marketed as BurstDR stimulation) for Proclaim IPGs with MDT headers and 4) Inclusion of the Lead & Extension Insertion Tool (LEIT).