LEAD TUNNELER MODEL 6888
FDA premarket approval P830060/S062 · decided 2010-11-10
Approval details
- PMA number
- P830060
- Supplement
- S062
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEAD TUNNELER MODEL 6888
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-02-24
- Decision date
- 2010-11-10
- Days to decision
- 624 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES.
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