EPT-1000XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S007 · decided 2004-10-12
Approval details
- PMA number
- P020025
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPT-1000XP CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2004-09-15
- Decision date
- 2004-10-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ELIMINATION OF A CLEANING AGENT FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF A NEW AUTOMATED UV CURING FIXTURE.
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