PROTECTA (D334TRG, D334VRG), PROTECTA XT (D314DRG, D314VRG)
FDA premarket approval P980016/S318 · decided 2011-08-18
Approval details
- PMA number
- P980016
- Supplement
- S318
- Supplement type
- 30-Day Notice
- Trade name
- PROTECTA (D334TRG, D334VRG), PROTECTA XT (D314DRG, D314VRG)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-07-20
- Decision date
- 2011-08-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO THE RADIO FREQUENCY TESTING OF HYBRIDS.
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