PMA P970035S003

Device: MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S003
Product code: MAF
Decision date: 1998-07-10
Generic name: STENT, CORONARY
Approval order 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.

Current openFDA PMA Record

Device: MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S003
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-07-10
Decision code: OK30
Date received: 1998-06-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.