BRIO IMPLANTABLE PULSE GENERATORS (IPGS)
FDA premarket approval P140009/S012 · decided 2016-03-03
Approval details
- PMA number
- P140009
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRIO IMPLANTABLE PULSE GENERATORS (IPGS)
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-02-02
- Decision date
- 2016-03-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Alternate manufacturing location for the SMT Level assemblies used in the manufacturing of the Implantable Pulse Generators (IPGs) and the external accessories for the Spinal Cord Stimulation and Deep Brain Stimulation systems.
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