MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
FDA premarket approval P970035/S003 · decided 1998-07-10
Approval details
- PMA number
- P970035
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 1998-06-23
- Decision date
- 1998-07-10
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Requested a revision in the Installation Qualification (IQ) and Operational Qualification (OQ) validations for the Strain Relief Equipment, as well as a revision int he preventative maintenance procedure for Strain Relief Equipment to include monthly wire integrity verification.
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