PMA P010068S020
- Device
- NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S020
- Product code
- OAD
- Decision date
- 2010-10-01
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
Current openFDA PMA Record#
- Device
- NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S020
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2010-10-01
- Decision code
- APPR
- Date received
- 2010-03-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.