PMA P010068S001
- Device
- NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S001
- Product code
- OAD
- Decision date
- 2003-02-04
- 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 ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.
Current openFDA PMA Record#
- Device
- NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S001
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2003-02-04
- Decision code
- APPR
- Date received
- 2003-01-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.