EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S014 · decided 2005-12-23
Approval details
- PMA number
- P020025
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2005-09-22
- Decision date
- 2005-12-23
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GROVE, ILLINOIS.
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