PMA P040003S001
- Device
- EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S001
- Product code
- LSY
- Decision date
- 2005-12-30
- Classification
- Ultrasound, Hyperthermia, Cancer Treatment
- Generic name
- Ultrasound, hyperthermia, cancer treatment
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT INSIGHTEC IMAGE GUIDED TREATMENT LTD., TIRAT CARMEL, ISRAEL.
Current openFDA PMA Record#
- Device
- EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S001
- Product code
- LSY
- Generic name
- Ultrasound, hyperthermia, cancer treatment
- Decision date
- 2005-12-30
- Decision code
- APPR
- Date received
- 2005-08-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT INSIGHTEC IMAGE GUIDED TREATMENT LTD., TIRAT CARMEL, ISRAEL.