Blazer II XP Cardiac Ablation Catheter and Cable
FDA premarket approval P020025/S126 · decided 2020-05-19
Approval details
- PMA number
- P020025
- Supplement
- S126
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Blazer II XP Cardiac Ablation Catheter and Cable
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2020-03-12
- Decision date
- 2020-05-19
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.
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