Blazer II XP Cardiac RF Ablation System
FDA premarket approval P020025/S105 · decided 2017-08-31
Approval details
- PMA number
- P020025
- Supplement
- S105
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Blazer II XP Cardiac RF Ablation System
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2017-08-04
- Decision date
- 2017-08-31
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Update the BSC2000-2 cycle conducted in Chamber 2 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, an additional vacuum pump booster, and a new validation documentation structure used to support the system.
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