INSYNC MODEL 8040 PULSE GENERATOR
FDA premarket approval P010015/S156 · decided 2012-04-02
Approval details
- PMA number
- P010015
- Supplement
- S156
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC MODEL 8040 PULSE GENERATOR
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2012-03-05
- Decision date
- 2012-04-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
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