PMA P950005S052
- Device
- CELSIUS FLTR UNI-DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S052
- Product code
- LPB
- Decision date
- 2014-09-12
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.
Current openFDA PMA Record#
- Device
- CELSIUS FLTR UNI-DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S052
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-09-12
- Decision code
- OK30
- Date received
- 2014-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.