GEM DR
FDA premarket approval P980016/S344 · decided 2012-04-02
Approval details
- PMA number
- P980016
- Supplement
- S344
- Supplement type
- 30-Day Notice
- Trade name
- GEM DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-03-07
- Decision date
- 2012-04-02
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
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