Product Code: MHY

Products Classified as MHY

3842

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Total Product Life Cycle (TPLC) Devices

3842

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Consensus Standards

• Stimulator, Electrical, Implanted, For Parkinsonian Tremor [36836]: 21 CFR Unclassified 🔎

Pre-market Approvals for MHY

P140009	4CH & 8CH Infinity DBS System FLex Extension	Abbott Medical
P960009	Activa Deep Brain Stimulation Therapy System	MEDTRONIC Inc.

Global Unique Device Identification Database

• 00613994798398: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994761088: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994761071: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994761064: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994749109: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994353504: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994348661: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994099099: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994099082: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994099075: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00643169108196: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00643169105492: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00613994997845: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00643169986435: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 00643169974821: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Maude Adverse Events

PERCEPT	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
8CH INFINITY DBS FLEX EXTN KIT, 60CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-30
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-30
8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-30
8CH INFINITY DBS FLEX EXTN KIT, 50CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-27
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-27
8CH INFINITY DBS FLEX EXTN KIT, 50CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-27
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-27
8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-27
8CH INFINITY DBS FLEX EXTN KIT, 50CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-27
NASTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	BOSTON SCIENTIFIC NEUROMODULATION	2020-03-27
IMPLANTABLE NEUROSTIMULATOR	MEDTRONIC NEUROMODULATION	2020-03-27
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-27
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-27
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-27
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-27
INFINITY? 7 IMPLANTABLE PULSE GENERATOR	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-27
8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26
IMPLANTABLE NEUROSTIMULATOR	MEDTRONIC NEUROMODULATION	2020-03-26
ACTIVA	MEDTRONIC NEUROMODULATION	2020-03-26
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-26
ACTIVA	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
ACTIVA	MEDTRONIC NEUROMODULATION	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
IMPLANTABLE NEUROSTIMULATOR	MEDTRONIC NEUROMODULATION	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
8CH INFINITY DBS FLEX EXTN KIT, 50CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26
8CH INFINITY DBS FLEX EXTN KIT, 60CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26
INFINITY? 7 IMPLANTABLE PULSE GENERATOR	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
ACTIVA	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-26
8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26
INFINITY? 5 IMPLANTABLE PULSE GENERATOR	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26
8CH INFINITY DBS FLEX EXTN KIT, 60CM, B	ST. JUDE MEDICAL - NEUROMODULATION	2020-03-26