MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE
FDA premarket approval P960009/S229 · decided 2015-11-17
Approval details
- PMA number
- P960009
- Supplement
- S229
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Medtronic, Inc.
- Date received
- 2015-05-21
- Decision date
- 2015-11-17
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A MODIFICATION TO THE INDICATION FOR USE (IFU) FOR THE MEDTRONIC DEEP BRAIN STIMULATION (BDS) THERAPY FOR PARKINSON¿S DISEASE AND CORRESPONDING LABELING CHANGES ASSOCIATED WITH THE IFU MODIFICATION. BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) USING MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS IN INDIVIDUALS WITH LEVODOPA-RESPONSIVE PARKINSON'S DISEASE OF AT LEAST 4
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |