EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003/S009 · decided 2011-03-09
Approval details
- PMA number
- P090003
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2011-02-08
- Decision date
- 2011-03-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- MODIFICATION IN THE BALLOON WINGFOLDING OPERATION DURING MANUFACTURE OF THE EXPRESS¿ LD ILIAC PREMOUNTED STENT SYSTEM.
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