PMA P150005
- Device
- Intellagen™ Irrigation Tubing Set
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S072
- Product code
- OAD
- Decision date
- 2025-12-05
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval for a new sterile pouch with direct label print and new tubing ink for the INTELLAGEN Tubing Set
Current openFDA PMA Record#
- Device
- Intellagen™ Irrigation Tubing Set
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S090
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2025-12-05
- Decision code
- APPR
- Date received
- 2025-09-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new sterile pouch with direct label print and new tubing ink for the INTELLAGEN Tubing Set