PMA P010055S004
- Device
- CORETHERM CATHETER
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S004
- Product code
- MEQ
- Decision date
- 2007-06-19
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- CHANGE IN THE MATERIAL USED IN THE IP-SEAL OF THE DEVICE.
Current openFDA PMA Record#
- Device
- CORETHERM CATHETER
- Applicant
- Prostalund AB
- PMA number
- P010055
- Supplement
- S004
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2007-06-19
- Decision code
- OK30
- Date received
- 2007-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MATERIAL USED IN THE IP-SEAL OF THE DEVICE.