- Device
- EZ STEER 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S012
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2008-02-01
- Decision code
- APPR
- Date received
- 2007-12-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.