Blazer II XP and Blazer Prime XP
FDA premarket approval P020025/S116 · decided 2018-11-28
Approval details
- PMA number
- P020025
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Blazer II XP and Blazer Prime XP
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2018-10-30
- Decision date
- 2018-11-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Addition of new electrical test equipment for use with Blazer II, Blazer II XP, and Blazer Prime Ablation catheters.
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