PMA P010032S088
- Device
- EON TM, EONC TM, PROTEGE, PROTEGE MRI AND BRIO IMPLANTABLE PULSE GENERATOR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S088
- Product code
- LGW
- Decision date
- 2014-12-19
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- REPLACE THE AK-225 SOLVENT USED DURING THE MANUFACTURING PROCESS OF THE IMPLANTABLE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- EON TM, EONC TM, PROTEGE, PROTEGE MRI AND BRIO IMPLANTABLE PULSE GENERATOR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S088
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-12-19
- Decision code
- OK30
- Date received
- 2014-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE AK-225 SOLVENT USED DURING THE MANUFACTURING PROCESS OF THE IMPLANTABLE PULSE GENERATORS.