MAESTRO 3000 CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S030 · decided 2011-08-18
Approval details
- PMA number
- P020025
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2011-07-20
- Decision date
- 2011-08-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- EIGHT (8 ) TEST APPLICATION CHANGES TO THE FINAL FUNCTIONAL TEST RELEASE.
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