MAESTRO 3000 CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S059 · decided 2014-10-17
Approval details
- PMA number
- P020025
- Supplement
- S059
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAESTRO 3000 CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2014-05-05
- Decision date
- 2014-10-17
- Days to decision
- 165 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 STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.