- Device
- IntellaNav XP and IntellaNav MiFi XP ablation catheters
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S128
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-06-17
- Decision code
- OK30
- Date received
- 2020-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative supplier of the PCBA component used in the BSC IntellaNav XP and IntellaNav MiFi XP ablation catheters.