IntellaNav ST
FDA premarket approval P920047/S112 · decided 2019-01-09
Approval details
- PMA number
- P920047
- Supplement
- S112
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IntellaNav ST
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2018-10-25
- Decision date
- 2019-01-09
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of manufacturing changes, specifically, the addition of BSC Heredia as an alternate supplier for the Steering Control Wire Subassembly.
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| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
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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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