CAROTID WALLSTENT ENDOPROSTHESIS
FDA premarket approval P050019/S021 · decided 2015-05-15
Approval details
- PMA number
- P050019
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAROTID WALLSTENT ENDOPROSTHESIS
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific Corp
- Date received
- 2015-02-23
- Decision date
- 2015-05-15
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR LABELING CHANGES RELATED TO THE MR COMPATIBILITY OF THE DEVICE.
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
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