PMA P950005S079
- Device
- CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S079
- Product code
- LPB
- Decision date
- 2021-04-27
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Procedure to repackage and relabel products with secondary packaging damage.
Current openFDA PMA Record#
- Device
- CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S079
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-04-27
- Decision code
- OK30
- Date received
- 2021-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Procedure to repackage and relabel products with secondary packaging damage.