GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM
FDA premarket approval P970035/S016 · decided 1999-05-14
Approval details
- PMA number
- P970035
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 1999-04-26
- Decision date
- 1999-05-14
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- The 30-Day Notice requested that GFX(R) ring components annealed at 985 degrees Celsius for 20 minutes be utilized for the manufacturing of the GFX2 stent component. The change is being requested in order to utilize the existing inventory of GFX ring components for the manufacture of GFX2 stent.
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