Wallstent Venous Endoprosthesis with UNISTEP Plus
FDA premarket approval P980033/S053 · decided 2019-04-17
Approval details
- PMA number
- P980033
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Wallstent Venous Endoprosthesis with UNISTEP Plus
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-03-22
- Decision date
- 2019-04-17
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Add an existing EO sterilization cycle to an additional chamber in order to increase cycle capacity.
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