ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
FDA premarket approval P960009/S240 · decided 2015-11-12
Approval details
- PMA number
- P960009
- Supplement
- S240
- 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
- 2015-10-13
- Decision date
- 2015-11-12
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLATABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.
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