PMA P010032S094
- Device
- GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S094
- Product code
- LGW
- Decision date
- 2015-03-24
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2321 AND 2326) FOR THE SPINAL CORD STIMULATION SYSTEM. THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL BOSTON SCIENTIFIC LEAD OR EXTENSION TO A COMPATIBLE ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR.
Current openFDA PMA Record#
- Device
- GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S094
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-03-24
- Decision code
- APPR
- Date received
- 2014-12-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2321 AND 2326) FOR THE SPINAL CORD STIMULATION SYSTEM. THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL BOSTON SCIENTIFIC LEAD OR EXTENSION TO A COMPATIBLE ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR.