PMA P950005S058
- Device
- CELSIUS FLTR UNI -DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S058
- Product code
- LPB
- Decision date
- 2015-08-18
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP.
Current openFDA PMA Record#
- Device
- CELSIUS FLTR UNI -DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S058
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2015-08-18
- Decision code
- OK30
- Date received
- 2015-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP.