MAESTRO 4000 CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S060 · decided 2014-12-19
Approval details
- PMA number
- P020025
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAESTRO 4000 CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2014-06-10
- Decision date
- 2014-12-19
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DESIGN CHANGES, LABELING CHANGES, AND A MANUFACTURING SITE CHANGE OF THE STERLLARTECH RESEARCH CORPORATION FROM SUNNYVALE, CA TO MILPITAS, CA FORTHE MAESTRO 4000 CARDIAC ABLATION SYSTEM.
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