VARIOUS FAMILIS OF ICDS
FDA premarket approval P980016/S140 · decided 2009-01-06
Approval details
- PMA number
- P980016
- Supplement
- S140
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VARIOUS FAMILIS OF ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-07-02
- Decision date
- 2009-01-06
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGING THE MANUFACTURING PROCESS OF A RECTIFIER DIODE AND A THYRISTOR.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.