INSYNC IPG MODEL 8040 BIVENTRICULAR PULSE GENERATOR SYSTEM
FDA premarket approval P010015/S002 · decided 2001-12-11
Approval details
- PMA number
- P010015
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC IPG MODEL 8040 BIVENTRICULAR PULSE GENERATOR SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2001-11-05
- Decision date
- 2001-12-11
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
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