Blazer II XP; Blazer Prime XP
FDA premarket approval P020025/S093 · decided 2016-12-23
Approval details
- PMA number
- P020025
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Blazer II XP; Blazer Prime XP
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2016-11-22
- Decision date
- 2016-12-23
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change to the Ultrasonic Welding process used to secure the steering knob during manufacture of Blazer II, Blazer II XP, Blazer II HTD, Blazer Prime XP, and Blazer Prime HTD temperature ablation catheters.
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