MAESTRO 3000 TM CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S012 · decided 2005-10-18
Approval details
- PMA number
- P020025
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Trade name
- MAESTRO 3000 TM CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2005-07-18
- Decision date
- 2005-10-18
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATION TO THE HARDWARE, SOFTWARE, AND NEW ACCESSORIES OF THE EPT-1000 SERIES OF CARDIAC ABLATION SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAESTRO 3000 CARDIAC ABLATION SYSTEM AND IS INDICATED FOR USE, IN CARDIAC ABLATION PROCEDURES, WITH STANDARD AND HIGH-POWER BSC CARDIAC ABLATION CATHETERS SUCH THAT THE PHYSICIAN IS REFERRED TO THE INDIVIDUAL INSTRUCTIONS FOR USE FOR CATHETER COMPATIBILITY TO THE MAESTRO 3000 CARDIAC ABLATION SYSTEM. THE BOSTON
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