PMA P030031S054
- Device
- NAVISTAR THERMOCOOL
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S054
- Product code
- LPB
- Decision date
- 2013-08-22
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF A SECOND SOURCE SUPPLIER FOR THE MANUFACTURING OF TIP ELECTRODES FOR THE FAMILY OF PRODUCTS.
Current openFDA PMA Record#
- Device
- NAVISTAR THERMOCOOL
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S054
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2013-08-22
- Decision code
- OK30
- Date received
- 2013-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SECOND SOURCE SUPPLIER FOR THE MANUFACTURING OF TIP ELECTRODES FOR THE FAMILY OF PRODUCTS.