PMA P030031S085
- Device
- Biosense Webster NaviStar ThermoCool Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S085
- Product code
- OAD
- Decision date
- 2018-01-05
- 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 of the sponsors request to close out the OSB Lead-Atrial Fibrillation Registry PAS for the post-approval study (PAS).
Current openFDA PMA Record#
- Device
- Biosense Webster NaviStar ThermoCool Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S085
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2018-01-05
- Decision code
- APPR
- Date received
- 2017-10-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the sponsors request to close out the OSB Lead-Atrial Fibrillation Registry PAS for the post-approval study (PAS).