WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA premarket approval P980033/S015 · decided 2008-12-16
Approval details
- PMA number
- P980033
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Trade name
- WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Generic name
- Stent, central venous
- Applicant
- Boston Scientific Corporation
- Date received
- 2008-11-19
- Decision date
- 2008-12-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- QKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE IN THE STERILE LOAD CONFIGURATION AND THE STERILIZATION LOAD DENSITY OF THE CYCLE USED BY THE DEVICES.
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