DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
FDA premarket approval P820003/S089 · decided 2009-03-06
Approval details
- PMA number
- P820003
- Supplement
- S089
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-02-06
- Decision date
- 2009-03-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- TRANSFERRING THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGING PROCESS STEPS FOR THE MODEL 5409 POUCH-DISPOSABLE, 5PK TO THE CONTRACT MANUFACTURER¿S FACILITY IN MEDINA, MINNESOTA.
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