PMA P140009S075
- Device
- Infinity Deep Brain Stimulation (DBS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S075
- Product code
- MHY
- Decision date
- 2022-02-17
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Additional heat sealer (Accu Seal 6400 series) for use in the Plano facility.
Current openFDA PMA Record#
- Device
- Infinity Deep Brain Stimulation (DBS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S075
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2022-02-17
- Decision code
- OK30
- Date received
- 2022-01-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional heat sealer (Accu Seal 6400 series) for use in the Plano facility.