PMA P110016S063
- Device
- THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S063
- Product code
- OAD
- Decision date
- 2019-08-22
- 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 an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.
Current openFDA PMA Record#
- Device
- THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S063
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-08-22
- Decision code
- APPR
- Date received
- 2019-06-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.