MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
FDA premarket approval P970035/S007 · decided 1998-09-30
Approval details
- PMA number
- P970035
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 1998-09-22
- Decision date
- 1998-09-30
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Requested a change in the current balloon bond process from a manual to an automated process.
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