DISPOSABLE PATIENT CABLES
FDA premarket approval P820003/S118 · decided 2012-12-04
Approval details
- PMA number
- P820003
- Supplement
- S118
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISPOSABLE PATIENT CABLES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-11-06
- Decision date
- 2012-12-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING CHANGES TO THE D01 CONNECTOR AND SOLDER AND FLUX.
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