RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
FDA premarket approval P110038/S010 · decided 2015-11-18
Approval details
- PMA number
- P110038
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2015-10-19
- Decision date
- 2015-11-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP OF THE RELEASE GRIP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |