PMA P010068S004
- Device
- NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S004
- Product code
- OAD
- Decision date
- 2004-09-10
- 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 ALTERNATIVE STERILIZATION METHOD (I.E., EO EXPRESS FOR BIOLOGICAL INDICATOR RELEASE) FOR THE NAVISTAR DS 8MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER.
Current openFDA PMA Record#
- Device
- NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S004
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2004-09-10
- Decision code
- APPR
- Date received
- 2004-07-28
- Supplement type
- Real-Time Process
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATIVE STERILIZATION METHOD (I.E., EO EXPRESS FOR BIOLOGICAL INDICATOR RELEASE) FOR THE NAVISTAR DS 8MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER.