DISPOSABLE EPG COVER
FDA premarket approval P820003/S128 · decided 2014-03-12
Approval details
- PMA number
- P820003
- Supplement
- S128
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISPOSABLE EPG COVER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-02-27
- Decision date
- 2014-03-12
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.