WALLSTENT ENDOPROSTHESIS VENOUS
FDA premarket approval P980033/S032 · decided 2013-06-06
Approval details
- PMA number
- P980033
- Supplement
- S032
- 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
- 2013-05-09
- Decision date
- 2013-06-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- VENDOR LOCATION CHANGE.
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