PMA P920047S136
- Device
- RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S136
- Product code
- LPB
- Decision date
- 2025-03-31
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- the addition of a new injection molding machine at a supplier
Current openFDA PMA Record#
- Device
- RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S136
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2025-03-31
- Decision code
- OK30
- Date received
- 2025-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new injection molding machine at a supplier