PMA P010068S005
- Device
- CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S005
- Product code
- OAD
- Decision date
- 2004-11-16
- 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
- CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S005
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2004-11-16
- Decision code
- APPR
- Date received
- 2004-11-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.