PMA P990025S013
- Device
- NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S013
- Product code
- LPB
- Decision date
- 2007-08-23
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD.
Current openFDA PMA Record#
- Device
- NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990025
- Supplement
- S013
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2007-08-23
- Decision code
- OK30
- Date received
- 2007-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD.