PMA P030031S102
- Device
- NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter
- Applicant
- Biosense Webster, Inc.
- Product code
- OAD
- Decision date
- 2021-01-28
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- labeling updates
Current openFDA PMA Record#
- Device
- NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S102
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-01-28
- Decision code
- APPR
- Date received
- 2020-02-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- labeling updates