PMA P990025S032
- Device
- NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S032
- Product code
- LPB
- Decision date
- 2013-04-12
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS, S.A., IN VERVIERS, BELGIUM.
Current openFDA PMA Record#
- Device
- NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S032
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2013-04-12
- Decision code
- APPR
- Date received
- 2012-06-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS, S.A., IN VERVIERS, BELGIUM.