ANGIOLINK VASCULAR CLOSURE SYSTEM
FDA premarket approval P040022/S003 · decided 2007-05-24
Approval details
- PMA number
- P040022
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIOLINK VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Medtronic Vascular
- Date received
- 2007-03-08
- Decision date
- 2007-05-24
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR INCORPORATION OF THE FOLLOWING PROCESSING AND MATERIAL CHANGES TO THE DISTAL END OF THE VCS 1000 DILATOR: 1) CHANGE IN THE DILATOR MATERIAL FROM NYLON 11 TO PEBAX NYLON 4033 FOR THE DILATOR DISTAL TIP AND FROM NYLON 11 TO PEBAX NYLON 6033 FOR THE DILATOR DISTAL SHAFT; 2) ADDITION OF A RF AND/OR ALTERNATIVE THERMAL ENERGY SOURCE TO BOND THE DILATOR DISTAL TIP TO THE DISTAL SHAFT; AND 3) ADDITION OF A HEAT SHRINK SLEEVE TO ENHANCE THE BOND BETWEEN THE SHAFT AND THE DISTAL TIP.
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