PMA P990054
- Device
- CHILLI COOLED RPM CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P990054
- Product code
- LPB
- Decision date
- 2006-06-13
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER.
Current openFDA PMA Record#
- Device
- CHILLI COOLED RPM CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P990054
- Supplement
- S008
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2006-06-13
- Decision code
- OK30
- Date received
- 2006-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER.