ELECTROLESS NICKEL IMMERSION GOLD PROCESS (ENIG) PROCESS
FDA premarket approval P820003/S112 · decided 2011-09-16
Approval details
- PMA number
- P820003
- Supplement
- S112
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELECTROLESS NICKEL IMMERSION GOLD PROCESS (ENIG) PROCESS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-08-18
- Decision date
- 2011-09-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE FROM MANUAL TO AUTOMATED PROCESS AT A SUPPLIER LOCATION.
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