GORE HELIX SEPTAL OCCLUDER
FDA premarket approval P050006/S033 · decided 2012-12-26
Approval details
- PMA number
- P050006
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GORE HELIX SEPTAL OCCLUDER
- Generic name
- Transcatheter septal occluder
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2012-11-30
- Decision date
- 2012-12-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- ALTERNATE RESIN RAW MATERIAL FOR THE DEVICE.
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