PARADYM CRT-D, PARADYM RF CRT-D
FDA premarket approval P060027/S049 · decided 2013-03-26
Approval details
- PMA number
- P060027
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM CRT-D, PARADYM RF CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-02-25
- Decision date
- 2013-03-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGES TO THE PROCESS LIMITS FOR GASES USED TO FILL FINISHED DEVICES AND ALSO UPDATES TO THE GAS CONCENTRATION LIMITS WITHIN THE INTERNAL ATMOSPHERE FOR THE IMPLANTABLE PULSE GENERATORS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.