RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
FDA premarket approval P110038/S012 · decided 2016-09-19
Approval details
- PMA number
- P110038
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2016-06-21
- Decision date
- 2016-09-19
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval for an alternate material and joining method for the delivery system secondary sheath (also referred to as the constraining sleeve).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |