LIFESTENT VASCULAR STENT SYSTEM
FDA premarket approval P070014/S033 · decided 2012-09-12
Approval details
- PMA number
- P070014
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFESTENT VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2012-08-15
- Decision date
- 2012-09-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE SEPARATION OF THE MANUFACTURING AND INSPECTION RESPONSIBILITIES FOR THE MANUAL PRESS PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.