LD LLIAC PREMOUNTED STENT SYSTEM
FDA premarket approval P090003/S031 · decided 2014-04-24
Approval details
- PMA number
- P090003
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LD LLIAC PREMOUNTED STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-04-07
- Decision date
- 2014-04-24
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
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