PMA P990025S047
- Device
- NAVISTAR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S047
- Product code
- LPB
- Decision date
- 2015-11-05
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- NAVISTAR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S047
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2015-11-05
- Decision code
- OK30
- Date received
- 2015-10-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.