INSYNC III MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE
FDA premarket approval P010015/S009 · decided 2003-03-27
Approval details
- PMA number
- P010015
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC III MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2003-03-05
- Decision date
- 2003-03-27
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC B.V., EUROPEAN OPERATIONS CENTER, HEERLEN, THE NETHERLANDS. FINAL DEVICE PACKAGING WILL BE PERFORMED AT THIS FACILITY.
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