ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
FDA premarket approval P960009/S227 · decided 2015-06-08
Approval details
- PMA number
- P960009
- Supplement
- S227
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
- Applicant
- Medtronic, Inc.
- Date received
- 2015-05-11
- Decision date
- 2015-06-08
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- TRANSFER OF INCOMING INSPECTION ACTIVITIES, FOR A NUMBER OF DEVICE COMPONENTS USED IN THE MANUFACTURE OF NEUROMODULATION LEADS, EXTENSIONS AND ACCESSORIES FROM THE MEDTRONIC RICE CREEK MANUFACTURING FACILITY TO MEDTRONIC PUERTO RICO OPERATION CNETERS (MPROC) IN VILLALBA AND JUNCOS.RANSFER OF INCOMING INSPECTION ACTIVITIES.
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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 |