PMA P010032S098
- Device
- GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S098
- Product code
- LGW
- Decision date
- 2015-11-02
- 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) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS.
Current openFDA PMA Record#
- Device
- GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S098
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-11-02
- Decision code
- APPR
- Date received
- 2015-08-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS.