ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
FDA premarket approval P960009/S242 · decided 2015-12-23
Approval details
- PMA number
- P960009
- Supplement
- S242
- 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
- 2015-11-23
- Decision date
- 2015-12-23
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.
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