PMA P040042S028
- Device
- THERAPY DUAL 8 CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S028
- Product code
- OAD
- Decision date
- 2015-04-09
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
Current openFDA PMA Record#
- Device
- THERAPY DUAL 8 CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S028
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-04-09
- Decision code
- APPR
- Date received
- 2014-04-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.