EPT-1000 CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S002 · decided 2003-12-31
Approval details
- PMA number
- P020025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPT-1000 CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2003-11-03
- Decision date
- 2003-12-31
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A STERILIZATION FACILITY LOCATED AT COSMED OF RHODE ISLAND, INC., COVENTRY, RHODE ISLAND.
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