ANCURE SYSTEM
FDA premarket approval P990017/S038 · decided 2003-08-08
Approval details
- PMA number
- P990017
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ANCURE SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Boston Scientific Corp
- Date received
- 2003-02-10
- Decision date
- 2003-08-08
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.
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|---|---|---|
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| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| 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 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |