ANGIOLINK VASCULAR CLOSURE SYSTEM
FDA premarket approval P040022/S002 · decided 2006-11-01
Approval details
- PMA number
- P040022
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIOLINK VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Medtronic Vascular
- Date received
- 2006-07-17
- Decision date
- 2006-11-01
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STD MED, INC., STOUGHTON, MASSACHUSETTS.
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