Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor · Neurology
Open FDA's page for this record- PMA number
- P960009
- Supplement number
- S548
- Applicant
- Medtronic, Inc.
- Street 1
- 7000 Central Ave., NE
- City
- Minneapolis
- State
- MN
- Zip
- 55432
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Trade name
- Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
- Product code
- MHY
- Advisory committee
- NE
- Advisory committee description
- Neurology
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-30
- Decision date
- 2026-10-30
- Decision code
- OK30
- Ao statement
approval for the following three changes: 1) Adding a new surface mount technology (SMT) production line.2) Revision of the SMT manufacturing process sequence to perform automated optical inspection immediately following each SMT assembly stage.3) Addition of an equivalent solder paste inspection system and addition of a qualified de-paneling machine for PCBA production
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2133772, 1627487, 3010052483, 3018094310, 3009380063, 3015200795, 3010086866, 3003335547, 3003477135, 3003120897, 2135338, 3004593495, 3019807891, 2648729, 3038429246, 3006630150, 3004209178, 3010972758, 3005160949, 9616693, 3006705815, 2182207, 2133641, 2183744, 1928237, 2024311, 3010531069, 2649622, 3005210579, 2124215, 3015924373, 3013023969
- FEI number
- 1627487, 3000203466, 3000209794, 3010052483, 3018094310, 3009380063, 3015200795, 3010086866, 3003335547, 3003477135, 3003120897, 3004593495, 3004369318, 3019807891, 3005700659, 2648729, 3038429246, 3006630150, 3010972758, 3005160949, 3006705815, 2182207, 3002618605, 2183744, 1928237, 2024311, 3010531069, 2649622, 3005210579, 2124215, 3015924373, 3013023969