PMA P020025S095
- Device
- RF Filter Module
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S095
- Product code
- OAD
- Decision date
- 2017-06-23
- 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 Boston Scientific Corporation, 150 Baytech Drive, San Jose, California.
Current openFDA PMA Record#
- Device
- RF Filter Module
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S095
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-06-23
- Decision code
- APPR
- Date received
- 2017-02-16
- 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 Boston Scientific Corporation, 150 Baytech Drive, San Jose, California.