MODEL 6943 SPRINT(R) LEAD
FDA premarket approval P980050/S005 · decided 2001-07-11
Approval details
- PMA number
- P980050
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 6943 SPRINT(R) LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2001-06-14
- Decision date
- 2001-07-11
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO WITHDRAW THE ATRIAL INDICATION FOR THE MODEL 6943 LEAD.
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