WALLSTENT ENDOPROSTHESIS VENOUS
FDA premarket approval P980033/S046 · decided 2016-10-12
Approval details
- PMA number
- P980033
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WALLSTENT ENDOPROSTHESIS VENOUS
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2016-09-13
- Decision date
- 2016-10-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Equipment update to automate features and implementation of a manufacturing database.
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