MAESTRO 3000 CARDIAC ABLATION SYSTEM
FDA premarket approval P920047/S063 · decided 2013-12-05
Approval details
- PMA number
- P920047
- Supplement
- S063
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MAESTRO 3000 CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2013-10-31
- Decision date
- 2013-12-05
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MINOR LABELING CHANGES, INCLUDING UPDATES IN ACCORDANCE WITH IEC 60601-1 THIRD EDITION.
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