PMA P970029S027
- Device
- PEARL 8.0 HANDPIECE
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S027
- Product code
- MNO
- Decision date
- 2015-04-03
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: THE SPONSOR HAS REQUESTED TO PLACE THEIR PAS ON HOLD.
Current openFDA PMA Record#
- Device
- PEARL 8.0 HANDPIECE
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S027
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2015-04-03
- Decision code
- APPR
- Date received
- 2015-02-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: THE SPONSOR HAS REQUESTED TO PLACE THEIR PAS ON HOLD.