EPT-1000XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S044 · decided 2013-10-07
Approval details
- PMA number
- P020025
- Supplement
- S044
- 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
- 2013-09-09
- Decision date
- 2013-10-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR IEC 60601-1 3RD EDITION LABELING IMPLEMENTATION TO THE BLAZER II, BLAZER II XP/HTD, BLAZER PRIME XP/HTD AND CHILLI II CARDIAC ABLATION CATHETERS AND CABLES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.