PMA P920047S125
- Device
- IntellaNav ST
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S125
- Product code
- LPB
- Decision date
- 2021-09-07
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Addition of an inspection for an electrical component located inside the handle of IntellaNav catheters.
Current openFDA PMA Record#
- Device
- IntellaNav ST
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S125
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-09-07
- Decision code
- OK30
- Date received
- 2021-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an inspection for an electrical component located inside the handle of IntellaNav catheters.