ASTRON STENT SYSTEM
FDA premarket approval P140030/S001 · decided 2016-03-10
Approval details
- PMA number
- P140030
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ASTRON STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Biotronik AG
- Date received
- 2016-02-11
- Decision date
- 2016-03-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bülach
- Statement
- Removal of a second aeration phase after ethylene oxide sterilization.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K052757) | Biotronik AG | 2005-10-28 |