IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable
FDA premarket approval P020025/S130 · decided 2021-04-08
Approval details
- PMA number
- P020025
- Supplement
- S130
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2021-03-11
- Decision date
- 2021-04-08
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a manufacturing site located at Boston Scientific Corporation, 4100 Hamline Avenue North, Saint Paul, Minnesota, for the manufacturing, distribution, and warehousing activities for the IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.