PMA P030031S002
- Device
- NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S002
- Product code
- OAD
- Decision date
- 2006-05-05
- 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 MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
Current openFDA PMA Record#
- Device
- NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S002
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2006-05-05
- Decision code
- APPR
- Date received
- 2005-09-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.