EPT-1000 XP RF ABLATION SYSTEM
FDA premarket approval P020025/S045 · decided 2013-11-25
Approval details
- PMA number
- P020025
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPT-1000 XP RF ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2013-09-12
- Decision date
- 2013-11-25
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO ALLOW HEALTH CARE FACILITIES TO MANUALLY CLEAN AND RE-STERILIZE THE INTELLATIP MIFI XP CABLE UP TO 10 TIMES VIA ETHYLENE OXIDE OR STEAM AFTER INITIAL USE OF THE CABLES.
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