(D334TRG), PROTECTA XT (D314TRG)
FDA premarket approval P010031/S272 · decided 2011-08-18
Approval details
- PMA number
- P010031
- Supplement
- S272
- Supplement type
- 30-Day Notice
- Trade name
- (D334TRG), PROTECTA XT (D314TRG)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-07-20
- Decision date
- 2011-08-18
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO THE RADIO FREQUENCY TESTING OF HYBRIDS.
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