PMA P010032S119
- Device
- SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S119
- Product code
- LGW
- Decision date
- 2016-06-28
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.
Current openFDA PMA Record#
- Device
- SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S119
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-06-28
- Decision code
- OK30
- Date received
- 2016-06-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.