Femoral Introducer Sheath and Hemostasis(FISH) Device
FDA premarket approval P050043/S008 · decided 2018-09-19
Approval details
- PMA number
- P050043
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Femoral Introducer Sheath and Hemostasis(FISH) Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Morris Innovative Research, Inc.
- Date received
- 2018-07-30
- Decision date
- 2018-09-19
- Days to decision
- 51 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- Replacement of the current laser cutting equipment with a new laser cutting equipment for the SIS patch cutting operation.
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