EPT-1000 XP RF ABLATION SYSTEMS
FDA premarket approval P020025/S003 · decided 2004-01-07
Approval details
- PMA number
- P020025
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPT-1000 XP RF ABLATION SYSTEMS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2003-12-08
- Decision date
- 2004-01-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
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