WALLSTENT ENDO (VENOUS) STENT SYTEM
FDA premarket approval P980033/S026 · decided 2012-10-31
Approval details
- PMA number
- P980033
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Trade name
- WALLSTENT ENDO (VENOUS) STENT SYTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2012-10-15
- Decision date
- 2012-10-31
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
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