PMA P140009S078

Device: Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S078
Product code: MHY
Decision date: 2022-06-30
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Implement the previously approved feed-thru design at the Abbott PR manufacturing facility with their separate welding process.

Current openFDA PMA Record#

Device: Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S078
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2022-06-30
Decision code: OK30
Date received: 2022-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement the previously approved feed-thru design at the Abbott PR manufacturing facility with their separate welding process.