PMA P020025S119
- Device
- Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S119
- Product code
- OAD
- Decision date
- 2019-05-03
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Add a supplier for the yarn used for the control wire sleeve sub-assembly.
Current openFDA PMA Record#
- Device
- Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S119
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-05-03
- Decision code
- OK30
- Date received
- 2019-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a supplier for the yarn used for the control wire sleeve sub-assembly.