DEEP BRAIN STIMULATION SYSTEM (LIBRA, LIBRA XP)IPG'S; (LIBRA, BRIO) CLINICIAN PROGRAMMERS
FDA premarket approval P140009/S016 · decided 2016-06-28
Approval details
- PMA number
- P140009
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEEP BRAIN STIMULATION SYSTEM (LIBRA, LIBRA XP)IPG'S; (LIBRA, BRIO) CLINICIAN PROGRAMMERS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-06-13
- Decision date
- 2016-06-28
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- 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.
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