PMA P020025S133
- Device
- IntellaNav MiFi XP, IntellaNav XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S133
- Product code
- OAD
- Decision date
- 2021-09-07
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Addition of an inspection for an electrical component located inside the handle of IntellaNav catheters.
Current openFDA PMA Record#
- Device
- IntellaNav MiFi XP, IntellaNav XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S133
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-09-07
- Decision code
- OK30
- Date received
- 2021-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an inspection for an electrical component located inside the handle of IntellaNav catheters.