EASYTRAK 2 LV-1 AND IS-1 LEADS
FDA premarket approval P010012/S118 · decided 2006-06-23
Approval details
- PMA number
- P010012
- Supplement
- S118
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EASYTRAK 2 LV-1 AND IS-1 LEADS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2006-03-09
- Decision date
- 2006-06-23
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE AND WARNINGS AS PART OF THE PHYSICIAN MANUALS.
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