EASYTRAK 3 PACING LEAD
FDA premarket approval P010012/S009 · decided 2003-03-25
Approval details
- PMA number
- P010012
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EASYTRAK 3 PACING LEAD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2003-02-05
- Decision date
- 2003-03-25
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR TITANIUM OXIDE-IMPREGNATED SUTURE SLEEVE AND IS INDICATED FOR USE WITH GUIDANT EASYTRAK LEADS.
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