ANGIOLINK VASCULAR CLOSURE SYSTEM
FDA premarket approval P040022/S001 · decided 2006-10-02
Approval details
- PMA number
- P040022
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIOLINK VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Medtronic Vascular
- Date received
- 2006-05-15
- Decision date
- 2006-10-02
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR VARIOUS MANUFACTURING PROCESS CHANGES TO ENSURE CONSISTENCY.
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