EP TECH CARDIAC ABLATION SYSTEM
FDA premarket approval P920047/S031 · decided 2009-07-08
Approval details
- PMA number
- P920047
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- EP TECH CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2005-10-13
- Decision date
- 2009-07-08
- Days to decision
- 1364 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, SUNNYVALE, CALIFORNIA.
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