PMA P020025S124
- Device
- Blazer Prime XP and IntellaTip MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S124
- Product code
- OAD
- Decision date
- 2020-02-07
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Addition of BSC Heredia as an alternate supplier for the steering control wire sub-assembly.
Current openFDA PMA Record#
- Device
- Blazer Prime XP and IntellaTip MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S124
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-02-07
- Decision code
- OK30
- Date received
- 2020-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of BSC Heredia as an alternate supplier for the steering control wire sub-assembly.