EPT-1000XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S078 · decided 2015-09-15
Approval details
- PMA number
- P020025
- Supplement
- S078
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EPT-1000XP CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-08-18
- Decision date
- 2015-09-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LABELING MODIFICATIONS IN COMPLIANCE WITH ELECTRICAL AND EMC CONSENSUS STANDARDS.
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