MEDTRONIC SPRINT TM MODEL 6932 LEAD
FDA premarket approval P920015/S011 · decided 1996-07-26
Approval details
- PMA number
- P920015
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC SPRINT TM MODEL 6932 LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 1996-05-20
- Decision date
- 1996-07-26
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC PUERTO RICO, INC., VILLALBA WEST INDUSTRIAL AREA, VILLALBA, PUERTO RICO TO MANUFACTURE THE MEDTRONIC MODEL 6932 LEAD
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