EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD
FDA premarket approval P010012/S390 · decided 2015-06-30
Approval details
- PMA number
- P010012
- Supplement
- S390
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD
- Applicant
- Boston Scientific Corp
- Date received
- 2015-06-05
- Decision date
- 2015-06-30
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE INTERNAL INSPECTION REQUIREMENTS FOR MOISTURE CONTENT OF THE TWO PART MEDICAL ADHESIVE.
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