GEM DR
FDA premarket approval P980016/S342 · decided 2012-04-02
Approval details
- PMA number
- P980016
- Supplement
- S342
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-03-05
- Decision date
- 2012-04-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.