PMA P970020S018
- Device
- ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P970020
- Supplement
- S018
- Product code
- MAF
- Decision date
- 1999-08-13
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- The 30-Day Notice requested the elimination of the pre-expansion step for the 3.0 mm, 3.5 mm, and 4.0 mm sizes.
Current openFDA PMA Record#
- Device
- ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P970020
- Supplement
- S018
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-08-13
- Decision code
- OK30
- Date received
- 1999-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested the elimination of the pre-expansion step for the 3.0 mm, 3.5 mm, and 4.0 mm sizes.