MITRACLIP NT CLIP DELIVERY SYSTEM
FDA premarket approval P100009/S019 · decided 2016-06-24
Approval details
- PMA number
- P100009
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MITRACLIP NT CLIP DELIVERY SYSTEM
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-05-26
- Decision date
- 2016-06-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Add the option to sterilize the MitraClip NT Clip Delivery System (CDS) and Steerable Guide Catheter (SGC) at the existing alternate sterilization site.
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