PMA P010032S106
- Device
- EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S106
- Product code
- LGW
- Decision date
- 2015-12-04
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- MINOR MODIFICATION ON THE AUTOMATED MANUFACTURING TEST SOFTWARE FOR BOTH SPINAL CORD STIMULATION AND THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S106
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-12-04
- Decision code
- OK30
- Date received
- 2015-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MINOR MODIFICATION ON THE AUTOMATED MANUFACTURING TEST SOFTWARE FOR BOTH SPINAL CORD STIMULATION AND THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATORS.