PMA P150038S038
- Device
- Exablate Model 4000 System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S038
- Product code
- POH
- Decision date
- 2025-04-04
- Classification
- Neurology
- Generic name
- MR-guided focused ultrasound system
- Approval order statement
- a change to the ethylene oxide residuals testing frequency from every batch to once annually during annual sterilization requalification
Current openFDA PMA Record#
- Device
- Exablate Model 4000 System
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S038
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2025-04-04
- Decision code
- OK30
- Date received
- 2025-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the ethylene oxide residuals testing frequency from every batch to once annually during annual sterilization requalification