- Device
- Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S055
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2020-03-04
- Decision code
- OK30
- Date received
- 2020-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an alternative sampling plan for bacterial endotoxin testing performed at the Arecibo, Puerto Rico facility