PMA P020025S115
- Device
- IntellaNav XP and MiFI XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S115
- Product code
- OAD
- Decision date
- 2019-01-09
- 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 manufacturing changes, specifically, the addition of BSC Heredia as an alternate supplier for the Steering Control Wire Subassembly.
Current openFDA PMA Record#
- Device
- IntellaNav XP and MiFI XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S115
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-01-09
- Decision code
- APPR
- Date received
- 2018-10-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of manufacturing changes, specifically, the addition of BSC Heredia as an alternate supplier for the Steering Control Wire Subassembly.