PMA P010055S002
- Device
- CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S002
- Product code
- MEQ
- Decision date
- 2004-11-05
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MRI MANUFACTURING AND RESEARCH INC (MRI MEDICAL), 4700 S. OVERLAND DRIVE, TUCSON, ARIZONA 85714-3430. MRI MEDICAL WILL DUPLICATE MANUFACTURE THE MODIFIED PROSTALUND FEEDBACK TREATMENT (PLFT) CATHETER.
Current openFDA PMA Record#
- Device
- CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S002
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2004-11-05
- Decision code
- APPR
- Date received
- 2004-09-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MRI MANUFACTURING AND RESEARCH INC (MRI MEDICAL), 4700 S. OVERLAND DRIVE, TUCSON, ARIZONA 85714-3430. MRI MEDICAL WILL DUPLICATE MANUFACTURE THE MODIFIED PROSTALUND FEEDBACK TREATMENT (PLFT) CATHETER.