PMA P040014S023
- Device
- THERAPY CATHETER
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S023
- Product code
- LPB
- Decision date
- 2015-04-09
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- 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 CATHETER
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S023
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- 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.